Page 1

VISION THE PAN-AMERICAN JOURNAL OF OPHTHALMOLOGY ISSN 2219-4665 June 2013, Vol. 12(2)

Editorial Dantas PEC

Glaucoma Special Issue Editorial Tsai JC

Message from the President Mannis MJ

The RAND Consensus Study for Primary Open-Angle Glaucoma in Latin America Lerner SF

A Review of the Surgical Approaches to Glaucoma Treatment Spratt A & Lee RK

Ab Interno Trabeculectomy: a Comprehensive Review Liu TT et al

Severe Serous Macular Detachment in the setting of Hypotony and Complex Hypercoagulability Syndrome Fawzi AA et al

Novel Surgical Technique in Refractory Open Angle Glaucoma: Case Report Perez Grossmann, RA et al

Letter from the Chairman of the Board of Directors De La Pe単a W

Proud to be PAN-AMERICAN


Preserva la visión alcanzando las menores presiones-objetivo en más pacientes Investigadores de diversos estudios, (AGIS, Shirakashi, Shields) han comprobado que alcanzar y mantener la PIO entre 14 y 15 mmHg reduce la progresión de pérdida del campo visual1,2,3. Lumigan® alcanza la PIO-objetivo de 14/15 mmHg en un mayor número de pacientes: ®

vs. timolol 4

®

vs.

dorzolamida/ timolol 5

®

vs. latanoprost 6

Porcentaje de Pacientes que alcanzaron la PIO-Objetivo ≤14

21%

9%

17%

2%

19%

9%

Porcentaje de Pacientes que alcanzaron la PIO-Objetivo ≤15

31%

16%

24%

9%

29%

14%

Lumigan ® (bimatoprost) Forma farmacéutica y pr esentación. Composición. Cada ml contiene: 0,3 mg de bimatoprost. Vehículo: cloreto de sódio, fosfato de sódio presentación. esentación.Frascos cuenta-gotas conteniendo 5 ml de solución oftalmológica estéril de bimatoprost a 0,03%. USO ADULTO.Composición. hepta-hidratado, ácido cítrico mono-hidratado, ácido clorídrico y/o hidróxido de sódio, cloruro de benzalconio y agua purificada qsp. Indicaciones. LUMIGAN® (bimatoprost) es indicado para la reducción de la presión intra-ocular elevada en pacientes con glaucona o hipertensión ecauciones y Adver tencias. Advertencias. Fueron relatados aumento gradual del crescimiento Contraindicaciones. LUMIGAN® (bimatoprost) está contraindicado en pacientes con hipersensibilidad al bimatoprost o cualquier otro componente de la fórmula del producto. Pr Precauciones Advertencias. ocular.Contraindicaciones. de las pestañas en el largo y espesura, y oscurecimiento de las pestañas (en 22% de los pacientes después 3 meses, y 36% después 6 meses de tratamiento), y, oscurecimiento de los párpados (en 1 a <3% de los pacientes después 3 meses y 3 a 10% de los pacientes después 6 meses de tratamiento). También fue relatado oscurecimiento del íris en 0,2% de los pacientes tratados durante 3 meses y en 1,1% de los pacientes tratados durante 6 meses. Algunas de esas alteraciones pueden ser permanentes. Pacientes que deben recibir el tratamiento ecauciones LUMIGAN® (bimatoprost) no fue estudiado en pacientes con insuficiencia renal o hepática y por lo tanto debe ser utilizado con cautela en tales pacientes.Las lentes de contacto deben Precauciones de apenas uno de los ojos, deben ser informados a respecto de esas reacciones. Pr ser retiradas antes de la instilación de LUMIGAN® (bimatoprost) y pueden ser recolocadas 15 minutos después. Los pacientes deben ser advertidos de que el producto contiene cloruro de benzalconio, que es absorvido por las lentes hidrofílicas.Si más que un medicamento de uso tópico ocular estuviera siendo utilizado, se debe respetar un intervalo de por lo menos 5 minutos entre las aplicaciones.No está previsto que LUMIGAN® (bimatoprost) presente influencia sobre la capacidad del paciente conducir vehículos u operar máquinas, sin embargo, así como para cualquier colírio, puede ocurrir visión borrosa transitoria después de la instilación; en estos casos el paciente debe aguardar que la visión se normalice antes de conducir u operar máquinas. Interacciones medicamentosas. medicamentosas.Considerando que las concentraciones circulantes sistemicas de bimatoprost son extremadamente bajas después múltiplas instilaciones oculares (menos de 0,2 ng/ml), y, que hay varias vías encimáticas envueltas en la biotransformación de bimatoprost, no son previstas interacciones medicamentosas en humanos. eacciones adversas. LUMIGAN® (bimatoprost) es bien tolerado, pudiendo causar eventos adversos oculares leves a moderados y no graves.Eventos adversos ocurriendo en 10-40% de los pacientes que recibieron doses únicas diarias, durante No son conocidas incompatibilidades. RReacciones 3 meses, en orden decreciente de incidencia fueron: hiperenia conjuntival, crecimento de las pestañas y prurito ocular.Eventos adversos ocurriendo en aproximadamente 3 a < 10% de los pacientes, en orden decreciente de incidencia, incluyeron: sequedad ocular, ardor ocular, sensación de cuerpo estraño en el ojo, dolor ocular y distúrbios de la visión.Eventos adversos ocurriendo en 1 a <3% de los pacientes fueron: cefalea, eritema de los párpados, pigmentación de la piel periocular, irritación ocular, secreción ocular, astenopia, conjuntivitis alérgica, lagrimeo, y fotofobia.En menos de 1% de los pacientes fueron relatadas: inflamación intra-ocular, mencionada como iritis y pigmentación del íris, ceratitis puntiforme superficial, alteración de las pruebas de función hepática e infecciones (principalmente resfriados e infecciones de las vías respiratorias).Con tratamientos de 6 meses de duración fueron observados, además de los eventos adversos relatados más arriba, en aproximadamente 1 a <3% de los pacientes, edema conjuntival, blefaritis y astenia. En tratamientos de asociación con betabloqueador, durante 6 meses, además de los eventos de más arriba, fueron observados en aproximadamente 1 a <3% de los pacientes, erosión de la córnea, y empeoramiento de la acuidad visual. En menos de 1% de los pacientes, blefarospasmo, depresión, retracción de los párpados, Posología y Administración. hemorragia retiniana y vértigo.La frecuencia y gravedad de los eventos adversos fueron relacionados a la dosis, y, en general, ocurrieron cuando la dosis recomendada no fue seguida.Posología Administración.Aplicar una gota en el ojo afectado, una vez al día, a la noche. La dosis no debe exceder a una dosis única diaria, pues fue demostrado que la administración más frecuente puede disminuir el efecto hipotensor sobre la hipertensión ocular.LUMIGAN® (bimatoprost) puede ser administrado concomitantemente con otros productos oftálmicos tópicos para reducir la hipertensión intra-ocular, respetándose el intervalo de por lo menos 5 minutos entre la administración de los medicamentos. VENTA BAJO PRESCRIPCIÓN MÉDICA.“ESTE PRODUCTO ES UM MEDICAMENTO NUEVO AUNQUE LAS INVESTIGACIONES HAYAN INDICADO EFICACIA Y SEGURIDAD, CUANDO CORRECTAMENTE INDICADO, PUEDEN SURGIR REACCIONES ADVERSAS NO PREVISTAS, AÚN NO DESCRIPTAS O CONOCIDAS, EN CASO DE SOSPECHA DE REACCIÓN ADVERSA, EL MÉDICO RESPONSABLE DEBE SER NOTIFICADO. 1. The AGIS Investigators: The Advanced Glaucoma Intervetion Study - The Relationship Between Control of Intraocular Pressure and Visual Field Deterioration. Am. J. Ophthalmol, 130 (4): 429-40, 2000. 2. Shirakashi, M. et al: Intraocular Pressure-Dependent Progression of Visual Field Loss in Advanced Primary Open-Angle Glaucoma: A 15-Year Follow-Up. Ophthalmologica, 207: 1-5, 1993. 3. Mao, LK; Stewart, WC; Shields, MB: Correlation Between Intraocular Pressure Control and Progressive Glaucomatous Damage in Primary Open-Angle Glaucoma. Am. J. Ophthalmol, 111: 51-55, 1991. 4. Higginbotham, EJ et al. One-Year Comparison of Bimatoprost with Timolol in Patients with Glaucoma or Ocular Hypertension. Presented at American Academy Ophthalmology, Nov 11-14, 2001. 5. Gandolfi, S et al. Three-Month Comparison of Bimatoprost and Latanoprost in Patients with Glaucoma and Ocular Hypertension. Adv. Ther, 18 (3): 110-121, 2001. 6. Coleman, AL et al: A 3-Month Comparison of Bimatoprost with Timolol/Dorzolamide in Patients with Glaucoma or Ocular Hypertension. Presented at American Acedemy of Ophthalmol, New Orleans, La, 2001.

Mejor comodidad posológica: 1 vez al día. No requiere refrigeración. Presentación conteniendo 3 ml.


June 2013, Vol. 12(2) Membership, Associations and Editorial Guidelines Editor-in-Chief: Paulo Elias C. Dantas, MD Prof. of Ophthalmology Department of Ophthalmology Santa Casa of São Paulo, Brazil

Associate Editor-in-Chief: Lihteh Wu, MD (San José, Costa Rica)

Administrative Editorial Council: Mark Mannis, MD (PAAO President, Sacramento, CA, USA.), and William De La Peña, MD (PAOF Chairman, Montebello, CA, USA)

Section Editor, Cataracts: Nestor Gullo, MD (La Plata, Argentina)

Section Editor, Neurophthalmology: Karl Golnik, MD (Cincinnati, OH, USA)

Section Editor, Cornea and External Disease: Allan R. Slomovic, MD (Ontario, Canada)

Section Editor, Oncology: Rubens N. Belfort, MD (São Paulo, Brazil)

Section Editor, Prevention of Blindness: Fernando R. Barría von Bischhoffshausen, MD (Concepción, Chile)

Section Editor

Aims and scope:

Vision Pan-America (printed version ISSN 2219-4665, electronic version ISSN 2219-4673), the official publication of the Pan-American Association of Ophthalmology, is a quarterly fully peer reviewed scientific publication that publishes original research in Ophthalmology, including review articles on ophthalmic diseases and surgical techniques, clinical scientific studies, basic investigation, case reports, brief communications and letters to the editor in four languages: Spanish, English, Portuguese and French. In addition, the journal publishes critical reviews of new texts in ophthalmology deemed to be of importance to the Pan-American practitioner.

Section Editor, Refractive Surgery: Luis Izquierdo Jr, MD (Lima, Peru)

Section Editor, Eye Banking: Luciene Barbosa de Sousa, MD (São Paulo, Brazil)

Section Editor, Ophthalmic Section Editor, Retina and Plastics and Orbital Diseases: Chun Cheng Lin Yang, MD MSc Vitreous: Mauricio Maia, MD (San José, Costa Rica) (São Paulo, Brazil)

Section Editor, Genetics: Eduardo José Gil Duarte Silva, MD (Figueira da Foz, Portugal)

Section Editor, Pathology: J. Oscar Croxatto, MD (Buenos Aires, Argentina)

Section Editor, Statistics and Epidemiology: Niro Kasahara, MD (São Paulo, Brazil)

Section Editor, Glaucoma: James C. Tsai, MD (New Haven, CT, USA)

Section Editor, Pediatric Ophthalmology and Strabismus: Maria Estela Arroyo Yllanes, MD (México City, México)

Section Editor, Uveitis and Immunology: Lourdes Arellanes-García, MD (Mexico City, Mexico)

Editorial Advisory Board

Editorial Review Board

Denise de Freitas, MD (São Paulo, Brazil)

Alejandro Lichtinger, MD (Toronto, Ontario, Canada)

Maria Audina Berrocal, MD (Miami, FL, USA)

Eduardo Alfonso, MD (Miami, FL, USA)

Ashley Behrens, MD (Riyadh, Saudi Arabia)

Daniel Weil, MD (Buenos Aires, Argentina)

Eduardo Arenas, MD (Bogotá, Colombia)

Ana Luisa Höfling-Lima (São Paulo, Brazil)

Marian Macsai, MD (Chicago, IL, USA)

J. Fernando Arévalo, MD (Riyadh, Saudi Arabia)

Bruno Fontes, MD (Rio de Janeiro, Brazil)

Marie Eve Legare, MD (Quebec City, Canada)

Alfredo Sadun, MD (Los Angeles, CA, USA)

Carol L. Karp, MD (Miami, FL, USA)

Natalio Izquierdo, MD (San Juan, Puerto Rico)

Enrique Graue-Hernández, MD (Mexico City, Mexico)

Peter Quiros, MD (Los Angeles, CA, USA)

Eugenio Maul de La Puente (Santiago, Chile)

Renato Ambrósio Jr. (Rio de Janeiro, Brazil)

Follow us on Facebook and Twitter

Pan-American Association of Ophthalmology @paao_vision

Ivan Schwab, MD (Sacramento, CA, USA) Office Staff Managing Editor Teresa Bradshaw (Arlington, TX, USA)

Pan-American Association of Ophthalmology (PAAO) Pan-American Ophthalmological Foundation (PAOF) 1301 S Bowen Road #450, Arlington TX 76013 USA Tel: (817) 275-7553 • Fax: (817) 275-3961 Email: info@paao.org • www.paao.org

Production Editor Terri Grassi (Arlington, TX, USA)

Production Editor Mapy Padilla (Lima, Peru)

• Abbott Medical Optics Inc.

• Bausch & Lomb Inc.

• Alcon Inc.

• Carl Zeiss Meditec Inc.

• Johnson & Johnson Vision Care Latin America

PAOF INDUSTRY SPONSORS

• Merck & Co Inc.

• Allergan Inc.

3TouchMedia strategy

CREATIVE LATIN MEDIA, LLC. 2901 Clint Moore PMB. 117 Boca Raton FL. 33496 USA Tel: (561) 443 7192 Fax: (561) 443 7196 Atención al cliente: E-mail: suscripciones@clatinmedia.com

marketing

communication

Producida / Editada / Diseñada / Distribuida por: 3 Touch Media S.A.S.

Printed in Printer Colombiana S.A. – Colombia PAN-AMERICA


PAAO EXECUTIVE COMMITTEE 2011-2013 President Mark J. Mannis, MD President Elect Ana Luisa Höfling-Lima, MD Past President Cristián Luco, MD Vice President Peter A. Quiros, MD Executive Vice President J. Fernando Arévalo, MD FACS

Secretary, English Language Region James C. Tsai, MD MBA

Secretary, Spanish Language Region Lihteh Wu, MD

Associate Secretary, English Language Region Carol L. Karp, MD

Associate Secretary, Spanish Language Region Jorge E. Valdez García, MD MA

Secretary, Portuguese Language Region Paulo E.C. Dantas, MD

Executive Director Teresa Bradshaw

Associate Secretary, Portuguese Language Region Mauricio Maia, MD

PAOF BOARD Chairman of the Board William De La Peña, MD Past Chair Mr. Nelson Marques Vice Chair Mark J. Mannis, MD Secretary-Treasurer Liana Ventura, MD Executive Director Teresa J. Bradshaw

PAAO BOARD OF DIRECTORS 2011-2013 ARGENTINA Enrique S. Malbrán, Sr., MD1 Ernesto Ferrer Abad, MD1,3 Gustavo Federico Bodino, MD1 J. Ignacio Manzitti, MD1 Joaquin Alfredo Bafalluy, MD1 Juan Oscar Croxatto, MD4 Lidia López, MD4 María Celeste Mansilla, MD1 Nestor Gullo, Jr., MD4 Roberto N. Ebner, MD1 S. Fabián Lerner, MD4 BOLIVIA José Luis Sebastián Salas, MD3 José Vladimir Justiniano Talavera, MD1 Vania Licett García Aliaga, MD1 BRAZIL Bruno Machado Fontes, MD1 Eduardo Büchele Rodrigues, MD1 José Alvaro P. Gomes, MD4 Liana Maria V. de O. Ventura, MD PhD1 Luciene Barbosa de Sousa, MD4 Luciene Chaves Fernandes, MD4 Marco Antonio Rey de Faria, MD1,3 Maria Cristina Nishiwaki-Dantas, MD1 Mário Junqueira Nóbrega, MD1 Nilo Holzchuh, MD1 Paulo Augusto de Arruda Mello, MD PhD1 Rubens Belfort, Jr., MD PhD2 CANADA Allan R. Slomovic, MD PhD FRCS(C)1 Paul E. Rafuse, MD PhD FRCS(C)1,3 CHILE Cristián Luco, MD2 Fernando Barría von Bischhoffshausen, MD1,4 Francisco José Conte Silva, MD1 Gonzalo Matus, MD1 Javier Lagos Rodríguez, MD1 Juan Verdaguer Taradella, MD2 Pedro Bravo C., MD1,4 COLOMBIA Alvaro Rodríguez González, MD2 Angela María Fernández Delgado, MD1,4 Angela María Gutiérrez Marín, MD1 Carlos Alberto Restrepo Pelaez, MD1 H. Fernando Gómez Goyeneche, MD1,3 Pedro Ivan Navarro Naranjo, MD1 COSTA RICA Javier A. Montero Alpizar, MD1 Joaquín Martínez Arguedas, MD3 Lihteh Wu, MD4 Teo Evans, MD1

CUBA Caridad Chiang Rodríguez, MD1 Carlos Alberto Perea Ruiz, MD1 Marcelino Rio Torres, MD3 Reinaldo Ríos Caso, MD1 DOMINICAN REPUBLIC Joaquin Lora Hernández, MD1 Miguel Angel López Pimentel, MD1 Miriam Cortina, MD3 ECUADOR Gregorio Gabela, MD1,4 Patricio Flor Arteaga, MD1 Ximena Velasteguí Camorali, MD3 EL SALVADOR Carlos Eduardo Alas Gudiel, MD1 Jaime Ricardo Avila Guerra, MD3 Rodrigo Antonio Quesada Larez, MD1 GUATEMALA Paulina Castejón, MD1 Rudy Oliver Gutiérrez Díaz, MD1,3 HAITI Frantz Large, MD3 HONDURAS Doris Alvarado de Jaúregui, MD1,3 Sergio Rolando Zúñiga Castillo, MD1 MEXICO Cecilio Francisco Velasco Barona, MD4 Enrique L. Graue Wiechers, MD2 Humberto Ruiz Orozco, MD1,3 José Luis Tovilla Canales, MD4 Lourdes Arellanes, MD4 María Estela Arroyo Yllanes, MD4 Raul Macedo Cué, MD1 NICARAGUA Sylvia Bravo Mendiola, MD1,3 PANAMA Benjamín F. Boyd, MD2 Félix Emilio Ruiz Díaz, MD1,3 Miguel Fco. Wong Tang, MD1 PARAGUAY Cirila Espinola de Ruiz Díaz, MD1,3 Miriam R. Cano, MD1 PERU Dino Fernando Natteri Marmol, MD1 Francisco Contreras Campos, MD2 Juan Carlos Corbera Gonzalo, MD1 Juan Fernando Mendiola Solari, MD1 Miguel Guzmán Ahumada, MD3 Rocío Ardito Vega, MD1

PORTUGAL Eduardo José Gil Duarte Silva, MD PhD1 Maria Manuela Pires Carmona, MD1,3 PUERTO RICO Ian Piovanetti Pérez, MD1,3 María Hortencia Berrocal, MD1 SPAIN Carlos Cortés Valdés, MD1 Luis Fernández Vega Sanz, MD3 Miguel A. Zato Gómez de Liaño, MD PhD1 URUGUAY Alicia Martínez de Pacheco, MD1 María del Rosario Varallo, MD1 Miguel Zylberglajt Cordones, MD1,3 USA Alice R. McPherson, MD2 Andrew G. Lee, MD1 Anthony C. Arnold, MD1 Arun D. Singh, MD4 Bradley Dean Fouraker, MD1 Bradley R. Straatsma, MD JD2 Carl D. Regillo, MD1 Charles M. Zacks, MD1 David K. Coats, MD1 Eduardo C. Alfonso, MD1 George A. Williams, MD1 J. Bronwyn Bateman, MD2 James P. McCulley, MD1 John A. Irvine, MD1 Nelson R. Sabates, MD1 Paul R. Lichter, MD2 Richard K. Parrish, II, MD1 Richard L. Abbott, MD2 Robert B. Bhisitkul, MD PhD1 Robert C. Drews, MD2 Robert Ritch, MD1 Ruth D. Williams, MD3 Stephanie Jones Marioneaux, MD1 Stuart R. Seiff, MD1 VENEZUELA Claudia Luz Pabón Bejarano, MD1 Luis Felipe Rivero Caret, MD1 María Angélica Cortez Bernal, MD1 Morayma Coromoto Acevedo Sorondo, MD3 Oscar Vicente Beaujón Balbi, MD1 WEST INDIES Donovan Calder, BSc MBBS FRCS3 Terrence Allan, BSc MBBS FRCS1 1

Delegate PAAO Past President President, Affiliated National Society 4 President, Affiliated Subspecialty Society 2 3


EDITORIAL

Editorial Glaucoma Issue James C. Tsai, M.D., M.B.A. Glaucoma Section Editor

Editorial Paulo E.C. Dantas, MD Editor-in-Chief

First VPA special issue One of the advantages of having a strong, intellectually solid and active editorial board is that you can rely on it, without any doubt. In this very special issue, our Glaucoma Section Editor, Prof. James C. Tsai, Robert R. Young Professor of Ophthalmology and Visual Science; Chair, Department of Ophthalmology & Visual Science, Yale University School of Medicine; Chief of Ophthalmology, Yale-New Haven Hospital, puts together an impressive amount of specific information on glaucoma to update us on the current concepts on this challenging disease that affects over 80 million persons worldwide, with the collaboration of a group of international renowned ophthalmologists from the Americas. This is certainly a must-keep issue to be saved and consulted anytime, anywhere for ophthalmologists from around the world. It is also a benchmark issue, which will provide a platform for our plans of having at least one of our 4 annual issues covering a special area or a specific disease. Hope you all enjoy! Paulo E.C. Dantas, M.D. Editor-in-Chief Vision Pan-America, The Pan-American Journal of Ophthalmology pauloecdantas@uol.com.br pauloecdantas@me.com

As the Glaucoma Section Editor for Vision Pan-America (VPA), The Pan-American Journal of Ophthalmology, I am truly delighted that Paulo E.C. Dantas, M.D., Editorin-Chief of VPA, approached me with the idea of publishing a special edition issue on glaucoma. According to the World Health Organization, glaucoma is the second leading cause of global blindness, with over 80 million persons worldwide afflicted with the disease. Everyday new advances in the diagnosis and management of glaucoma are reported, and we are excited to share some of these innovative findings with you, the Pan-American reader. As an introduction, Dr. Fabian Lerner reports on the results of a Latin American consensus panel of glaucoma experts regarding the diagnosis and management of primary open angle glaucoma. In this summary of findings from a recently published paper in the American Journal of Ophthalmology, Dr. Lerner provides a unique perspective of the clinical management views of Latin American glaucoma practitioners and a comparison with panel opinions from their counterparts from the United States. Dr. Alexander Spratt and colleagues review the evidence for current surgical techniques in patients with glaucoma refractory to medical therapy. These incisional procedures include trabeculectomy, aqueous shunt implants, Ex-PRESS mini shunt, trabectome, iStent, and SOLX suprachoridal implant. Dr. Ting Ting Liu and colleagues then provide a comprehensive review of trabectome surgery, concluding that the ab interno trabeculectomy procedure is an effective and safe surgical approach for patients with various types of open angle glaucoma. Two interesting surgical case reports are then presented. Dr. Amani Fawzi and colleagues describe a patient with massive serous detachment of the macula in the setting of post-trabeculectomy ocular hypotony and complex hypercoagulability syndrome. Dr. Rodolfo Perez Grossmann and colleagues describe two patients with refractory open angle glaucoma undergoing a novel surgical technique (i.e. trabeculectomy with Mitomycin C and additional aqueous drainage to the suprachoroidal space). It is my sincere hope that this special edition of VPA will provide new knowledge and clinical pearls in the diagnosis and management of glaucoma, thus improving care and education for your patients with this vision-threatening disease. James C. Tsai, M.D., M.B.A. Glaucoma Section Editor Vision Pan-America, The Pan-American Journal of Ophthalmology james.tsai@yale.edu PAN-AMERICA

35


Vis. Pan-Am. 2013;12(2):36

Message from the President Dr. Mark Mannis President, Pan-American Association of Ophthalmology

From the PAAO President: My favorite Brazilian singer, Milton Nascimento, sings of Rio de Janeiro: “É um lugar diferente…é mais que um sonho”. Rio is a different place, and for the Pan-American Association, certainly more than a dream this year. This August, we will gather in this beautiful city in partnership with the Brazilian Council of Ophthalmology to call together the best of ophthalmology of the Americas. It is a particular pleasure for me to complete my term as President of the Pan-American in Rio to celebrate the truly amazing ophthalmologic community that is growing in the Americas. While there remain significant disparities in both the level of science as well as patient care in the Americas, there is clearly a steady movement toward more uniform educational standards and higher quality delivery of care. At the same time, some of the most innovative clinical science in vision is emerging from the countries of Latin America. The Pan-American Association is dedicated to this growth in ophthalmic education and clinical care. Over the past two years, we have endeavored to provide

36

PAN-AMERICA

not only excellent meetings and congresses, but, in addition, a variety of new e-learning instruments that will be available to all. My thanks must go to my wonderful Executive Committee, to the PAAO Board of Directors, to the many committee chairs and members who have produced so much, to the two presidents of the Pan American Foundation—Nelson Marques and William De La Peña - with whom I have been privileged to work, and, of course, to Teresa Bradshaw and her outstanding employees at the PAAO for their support and hard work. We must remember that, like Rio, our drive to make eye care in the Americas the best on the planet is definitely more than a dream. Mark J. Mannis, MD, FACS President Pan-American Association of Ophthalmology


Lerner SF. The RAND consensus in Latin America.

The RAND Consensus Study for Primary Open-Angle Glaucoma in Latin America S. Fabian Lerner, MD

Autor Correspondiente:

Fundacion para el Estudio del Glaucoma, and Facultad de Posgrado, Universidad Favaloro. Buenos Aires, Argentina.

S. Fabian Lerner. Fundacion para el Estudio del Glaucoma. Marcelo T. De Alvear 2010, 2-A. Buenos Aires, Argentina. E-mail: glaucomas@yahoo.com.ar and fabianlerner@fibertel.com

Funding: None Financial/propretary disclosure: None

Date of submission: 12/3/2013 Date of Approval: 09/04/2013

Abstract

Purpose: To report the results of a Latin American (LA) consensus panel regarding the diagnosis and management of primary open angle glaucoma, and to compare these results with those from a similar panel in the United States (US). Design: A RAND-like appropriateness methodology was used to assess glaucoma practice in LA. Methods: The 148 polling statements created for the RAND- like analysis in the US and 10 additional statements specific to glaucoma care in LA were presented to a panel of LA glaucoma experts. Panelists were polled in private using the RAND- like methodology prior to and after a panel meeting. Results: Consensus agreement or disagreement amongst LA experts was reached for 51.3% of statements prior to the meeting and increased to 66.5% in the private, anonymous post meeting polling (79.0% agreement, 21.0% disagreement). While there was a high degree of concordance (111 of 148 statements, 75%) between the results of this LA panel and the US panel, there were some notable exceptions relating to diagnostic and therapeutic decision-making. Conclusions: This RAND-like consensus methodology provides a perspective of how LA glaucoma practitioners view many aspects of glaucoma and compares these results with those obtained using a similar methodology from practitioners in the US. These findings may be helpful to ophthalmologists providing glaucoma care in LA and in other regions of the world.

Introduction

This article summarizes the findings of a recent paper published in the American Journal of Ophthalmology.1

Glaucoma is the second leading cause of blindness worldwide, estimated to affect approximately 70 million individuals.2 Significant advances have been made in the diagnosis and treatment of this group of diseases over the past two decades, and several large randomized multicenter clinical trials have shed light on the relationship between intraocular pressure (IOP) and glaucomatous damage.3-7 Despite the information from these and other studies, several aspects of glaucoma management remain based more on the personal experience of an individual practitioner. There is a paucity of information on how specialists view glaucoma and manage this disease in much of the developed and developing world. Latin America (LA) is one such area where there is a need for a better regional understanding of how one manages glaucomatous disease. One well recognized standard for combining scientific evidence with expert opinion is the modified RAND-like appropriateness methodology8 This is a method of consensus development based on a well-established means of deciding the clinical pertinence of a medical treatment or an intervention.8,9 This system has previously been validated for obtaining consensus with regard to glaucoma diagnosis and therapy by a group of panelists in the United States (US)9-10. We used the Rand-like method to conduct a consensus on diagnosis and management of Primary Open-Angle Glaucoma in LA, and compared these results with a similar study performed in the US.

Methods

The RAND-like appropriateness methodology applied in this study was similar to that employed in a study in the United States and used all 148 polling statements created for the US study9. PAN-AMERICA

37


REVIEW / Vis. Pan-Am. 2013;12(2):37-40

Ten additional statements pertaining to fixedcombination glaucoma therapy available in LA, but not in the US, were added for a total of 158 polling statements. The voting panel consisted of 8 glaucoma specialists, selected primarily due to their recognition as leaders in the LA glaucoma community, with fluency in English, being an important prerequisite qualification. There were 2 voting panel members from Argentina, Brazil and Colombia acccordingly, as well as one from Chile and Mexico. Panelists were required to attend the face-to-face panel meeting for methodological reasons. The polling statements were divided into the following categories: medical therapy, adjunctive medical therapy, assessment and modification of medical therapy; laser trabeculoplasty; glaucoma surgery; trabeculectomy; combined cataract and trabeculectomy; aqueous drainage devices; nonpenetrating glaucoma drainage surgery; diagnostic testing and general considerations. The panelists were provided with a comprehensive list of articles pertaining to the polling statements with an effort made to select literature with the highest possible level of evidence based on criteria from the Oxford Center for Evidence-Based Medicine.11 The list included only articles that met Oxford grading level 1 or 2, and had been published within the preceding 15 years. A series of syntheses dealing with major topics addressed in the polling statements, previously developed by the methodologist for the US study were made available to the voting panelists.9 The polling process began with a list of statements and all relevant articles and syntheses being electronically sent to each panelist, along with the instructions on grading polling statements. The panelists were given 2 weeks to review all documents after which they submitted responses electronically to a statistician who analyzed the results. The statistician was not a member of the steering committee or the voting panel, and further, had no financial relationship with any of the sponsors of the study or manufacturers of any products referenced directly or indirectly in the polling statements. None of the sponsors had access to, or influence over, the polling statements, selection of panel members, meeting location or date of the panel, or results of this study. Sponsors, or their representatives, were not allowed to attend any meetings related to this project. The steering committee was masked with regard to the individual responses of the panelists at all 38

PAN-AMERICA

times during the course of the process. Five weeks after the initial polling, all participants were invited to a meeting to discuss the results and to clarify any misinterpretations. Voting panel members in attendance reviewed the collective results pertaining to all 158 polling statements without knowledge of how any individual panelist voted for each statement. All panelists attending the panel meeting voted again within two weeks of the meeting, using the same methodology as in the initial voting process. The results of this second polling were considered final and are presented here.

Results

There was consensus agreement or disagreement for 51.3% (81 of 158) and 66.5% (105 of 158) of the polling statements in the pre and post- panel meeting voting respectively. Seventy nine percent of the post meeting consensus statements where consensus was reached represented agreement with the polling statement with the remaining twenty-one representing disagreement. In the US study, the panel reached consensus in 55.4%, increasing to 74.3% of statements after the meeting (71.8% consensus agreement).10 There were some notable differences between glaucoma practitioners from the US and those practicing in LA. In the medical therapy section, the US panel agreed to consider topical carbonic anhydrase inhibitors (CAIs) or alpha agonists as acceptable for first-line therapy, while the LA panel was indeterminate. The US experts disagreed and the LA experts were indeterminate regarding the use of a fixed combination agent (topical CAI and beta-blocker) as first-line therapy. While the US panel reached consensus agreement that medical therapy should be initiated with a one-eye trial, the LA panel was indeterminate on this issue. The LA panel deemed the availability of a drug sample in the office as being less important in choosing a therapeutic agent than the US panel and was indeterminate regarding consideration of race or ethnicity in such a choice while the US panel disagreed with this latter polling statement. The US panel agreed and the LA panel was indeterminate with regard to the importance of age as a factor for choosing a therapeutic class of drugs. No differences were found between panels regarding indications for laser trabeculoplasty and glaucoma surgery. While the LA panel agreed that Mitomycin C should be used


Lerner SF. The RAND consensus in Latin America.

routinely as an adjunct with combined cataract and glaucoma procedures, the US experts were indeterminate on this issue. Differences in the use of glaucoma drainage devices (GDD) included the LA panel agreeing to consider GDD implantation as an alternative to trabeculectomy with the US panel being indeterminate on this issue. The US panel disagreed in considering nonpenetrating glaucoma surgery (NPGS) as an acceptable alternative surgery to trabeculectomy for maximal lowering of IOP, and agreed in that NPGS has a lower postoperative complication rate than trabeculectomy with the LA panel being indeterminate with regard to both of these statements. Regarding diagnostic testing, the LA panel agreed that stereo disk photographs are more useful than nonphotographic imaging of the disk for diagnosing glaucoma, while the US panel was indeterminate on this issue. The US panel disagreed, and the Latin American panel was indeterminate in considering standard automated perimetry (SITA) as the gold standard for diagnosing glaucoma. The US experts agreed that frequency doubling perimetry can detect glaucoma or glaucoma progression earlier than standard automatic visual field testing, and that central corneal thickness should be measured in all POAG patients while the Latin American panel was indeterminate with regard to these two statements. There was one polling statement for which there was absolute discordance between the LA and the U.S. panels. The LA and US panelists reached consensus agreement and disagreement respectively with the necessity of advancing therapy when IOP consistently exceeded the target pressure, even without documented optic nerve or visual field progression.

Discussion

While there have been many large multicenter clinical trials to support decisions in glaucoma practice in recent years, many and perhaps most decision making remains based upon clinical impressions and expert opinion.2-6,12-13 The information from trials does not address all aspects of glaucoma management, and even when such evidence is available, one must consider that the subject profiles of those randomized in such trials are not always similar to patients seen in routine practice. Consensus methodology has been developed in an effort to merge available evidence-based data with expert opinion. The modified RAND-like approach is one

such methodology that is believed to have a significant impact on practice patterns.14 The population of LA and the Caribbean is projected to increase from 580 million in 2009 to 724 million in the year 2050.15 The population and life expectancy increase, combined with the importance of age as a risk factor for glaucomatous disease, will lead to glaucoma becoming an increasingly important public health problem in LA over the coming decades. Using models based on prevalence studies performed on Hispanic residents of the US, it has been estimated that by the year 2020, 12.9% of the global open-angle glaucoma population will reside in LA.1 Currently; there is no specific information available in the peerreviewed literature pertaining to glaucoma diagnosis and treatment in this region of the world. The modified RAND- like methodology presented in this paper reflects the current glaucoma practice patterns for open-angle glaucoma in LA. Some notable highlights of the panel results include agreement with the use of prostaglandin analogs as the preferred firstline agents for glaucoma therapy, with other classes deemed acceptable for initial therapy. Compliance with therapy was determined to be inversely related to the number of eyedrops used each day. Difficulties in the assessment of compliance with medications for chronic conditions such as glaucoma persist and other specific medication related factors might also play an important role in influencing compliance.16-18 The factors found to be most relevant to choosing a therapeutic class of drugs related to the efficacy and tolerability of available agents. The panel generally agreed on the definitions of â&#x20AC;&#x153;non-complianceâ&#x20AC;? with therapy and the value of setting a target IOP goal when commencing therapy. There was also agreement that when there is nonresponse to initial therapy, switching classes or switching within a class is preferable to adding another medication. The LA experts voted in favor of what is optimal for individual patients rather than what is most convenient for the practitioner. In terms of advancement of treatment, the panel voted to proceed to the next therapeutic step when disease progression was noted on any of a number of parameters or, when a predetermined target IOP goal had not been reached, even in the absence of progression. One topic that has not been previously well studied in LA is the use of fixed combinations as first-line agents. In PAN-AMERICA

39


REVIEW / Vis. Pan-Am. 2013;12(2):37-40

particular, prostaglandin-beta blocker fixed combination agents are not available in the US and some other developed countries. It is noteworthy that the panel disagreed with the use of the prostaglandin â&#x20AC;&#x201C; betablocker analog as first-line fixed combination therapy perhaps reflecting a viewpoint that a prostaglandin alone may be almost as efficacious in terms of IOP lowering without the added costs and systemic risks associate with beta-blocker therapy. With regards to laser trabeculoplasty, the LA panel did not recommended it as a first-line option for treatment of POAG, but agreed that it should be used as an alternative to second or third-line therapy. Although the results of the Glaucoma Laser Trial determined that initial treatment with argon laser trabeculoplasty was at least as efficacious as initial medical treatment, this study was conducted prior to the availability of several contemporary classes of glaucoma medications, and the panel was not convinced that laser trabeculoplasty is presently an ideal first-line therapeutic choice for POAG.12 There was generally strong agreement amongst the panelists in the glaucoma surgery category. It appears that despite the increasing popularity of non-penetrating and drainage device procedures globally, trabeculectomy remains the gold standard surgical procedure for glaucoma in LA. There was also agreement that antifibrotic agents should routinely be used as adjuncts with trabeculectomy and, in the case of combined glaucoma and cataract procedures, mitomycin C was deemed preferable to 5-FU. Glaucoma drainage devices were considered an alternative to trabeculectomy in most cases, although it was agreed that lower IOP could be obtained with mitomycin-C augmented trabeculectomy. It is noteworthy that the threeyear postoperative follow-up report of the Tube versus Trabeculectomy Study showed a higher success rate for the tube group with similar mean IOP and number of postoperative medications, but higher cumulative probability of failure in the trabeculectomy with mitomycin-C group relative to the drainage device group.19 The overall incidence of complications was also higher in the trabeculectomy group in this study.19 Despite these findings, it appears that LA practitioners generally prefer trabeculectomy over drainage device implantation, particularly as an initial surgical procedure for glaucoma refractory to medical and laser therapy. The group agreed that disc photos are needed to manage glaucoma, and that stereo

40

PAN-AMERICA

disc photos are preferable. The preference for stereo disc photos over imaging devices was in concurrence with previous studies, although some reports have shown comparable results between these two methods to measure structural damage related to glaucomatous disease.20-21 In general, the panelâ&#x20AC;&#x2122;s views on the frequency of required structural and functional assessment of the optic nerve as well as gonioscopy were similar to those recommended by the AAO in their Preferred Practice Pattern document. There was strong agreement that the presence of structural damage, even without functional loss, may be considered an indication to initiate IOP lowering treatment. A consensus was reached that progression, either structural or functional, is an indication to advance therapy. The results of this panel suggest that LA glaucoma experts recognize the importance of diagnosing glaucoma in the earliest stages, sometimes prior to visual manifestations on automated perimetry. In comparing the results of this LA RAND-like methodology study with a previously published similar study in the US, it is noteworthy that there was strong concordance between the two studies with no differences found for 111 of 148 statements (75%) and complete discordance found for only one statement. One major reason for such strong overall concordance might be that the majority of LA panelists in this study practice in urban areas with greater wealth and access to care than found in many rural regions of the continent. LA is a large region of the world, the practice patterns of which cannot be fully represented by the handful of experts involved in this project. Every effort was made to assemble a panel including individuals of diverse backgrounds with regard to glaucoma training and region of practice. While not perfect, the views of these experts pertaining to glaucoma care in LA are more relevant to that region than the views of similarly trained individuals practicing in North America and Europe. Region specific practice patterns are best assessed by engaging those who are familiar with the diagnosis and management of glaucoma in the areas being evaluated. We are hopeful that this paper will provide a summary of such practice patterns to those involved in glaucoma care in LA and will serve as a stimulus for other comparative assessments in this region and throughout the world.

REFERENCES 1. Lerner SF, Singh KS, Susanna Jr, R, et al. Rand-like appropriateness methodology consensus for Primary-Open Glaucoma in Latin America. Am J Ophthalmology 2012;154:460-465. 2. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol 2006;90(3):262-267. 3. Heijl A, Leske C, Bengtsson B, Hyman L, Bengtsson B, Hussein M. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 2002;120(10):1268-1279. 4. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol 2002;120(6):701-713. 5. The AGIS Investigators. The Advance Glaucoma Intervention Study (AGIS):7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol 2000;130(4):429440. 6. Lichter PR, Musch DC, Gillespie BW, et al. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology 2001;108(11):1943-1953. 7. Collaborative Normal Tension Glaucoma Study Group. The Effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Am J Ophthalmol 1998;126(4):498-505. 8. Hicks NR. Some observations on attempts to measure appropriateness of care. BMJ 1994 Sep 17;309(6956):730733. 9. Wilson MR, Lee PP, Weinreb RN, Lee BL, Singh K; Glaucoma modified Randlike methodology group. A Panel assessment of glaucoma management: modification of existing Rand-like methodology for consensus in ophthalmology. Part I: methodology and design. Am J Ophthalmol 2008(3);145:570-574. 10. Singh K, Lee BL, Wilson MR; Glaucoma modified Rand-like methodology group. A Panel assessment of glaucoma management: modification of existing Rand-like methodology for consensus in ophthalmology. Part II: Results and Interpretation. Am J Ophthalmol 2008;145 (3):575-581. 11. Oxford Centre for Evidence-Based Medicine Levels of Evidence (March 2009). Available at http://www. cebm.net/index.aspx?o=1025. Accessed March 8, 2012. 12. The Glaucoma Laser Trial Research Group. The Glaucoma Laser Trial (GLT) and Glaucoma Laser Trial followup study: 7. Results. Am J

Ophthalmol 1995;120(6):718731. 13. The Fluorouracil Filtering Surgery Study Group. Fiveyear follow-up of the Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol 1996;121(4):349-366. 14. Campbell SM, Cantrill JA. Consensus methods in prescribing research. J Clin Pharm Ther 2001;26(1):5-14. 15. PRB staff. World population highlights: key findings from PRBs 2009 World Population Datasheet. Population Bulletin 2009;64(3):2-3. 16. Patel SC, Spaeth G. Compliance in patients prescribed eye drops for glaucoma. Ophthalmic Surg 1995;26(3):233-236. 17. Tsai J. Medication adherence in glaucoma. Approaches for optimizing patient compliance. Curr Opin Ophthalmol 2006;17(2):190-195. 18. Schwartz GF, Quigley HA. Adherence and persistence with glaucoma therapy. Surv Opthalmol 2008;53 Suppl 1:S57-S68. 19. Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL. Three-year follow-up of the tube versus trabeculectomy study. Am J Ophthalmol 2009;148(5):670-684. 20. DeLeon-Ortega JE, Arthur SN, McGwin Jr E, Xie A, Monheit BE, Girkin CA. Discrimination between glaucomatous and non-glaucomatous eyes using quantitative imaging devices and subjective optic nerve assessment. Invest Ophthalmol Vis Sci 2006;47(8):3774-80. 21. Reus NJ, de Graaf M, Lemij HG. Accuracy of GDx VCC, HRT I and clinical assessment of stereoscopic optic nerve head photographs for diagnosing glaucoma. Br J Ophthalmol 2007;91(3):313-8. Latin America Glaucoma Rand Study Group. Steering Committee: S. Fabian Lerner, Kuldev Singh, Remo Susanna Jr, M. Roy Wilson. Panel of Experts: Argentina: Daniel Grigera, Patricio Schlottmann. Brazil: Remo Susanna Jr., Ivan Tavares. Chile: Joao Lopes. Colombia: Fernando Gomez, Juan Carlos Rueda. Mexico: Curt Hartleben.


Spratt A & Lee RK. Surgical approaches to glaucoma treatment.

A review of the surgical approaches to glaucoma treatment

Alexander Spratt, MBBCh, FRCOphth and Richard K. Lee, MD, PhD

Correspondence to:

Bascom Palmer Eye Institute

Richard K. Lee, MD, PhD Bascom Palmer Eye Institute University of Miami Miller School of Medicine 900 NW 17th Street Miami, FL 33136 rlee@med.miami.edu

Funding: None Financial/propretary disclosure: None

Date of submission: 12/3/2013 y Date of Approval: 09/04/2013

Introduction

The conventional approach of initially treating glaucoma medically and holding surgical intervention as a reserve option was endorsed by the findings of the Collaborative Initial Glaucoma Treatment Study (CIGTS) study.1 This study reported that patients had similar visual field outcomes at five years from either medical treatment or immediate filtration surgery and supported the status quo of glaucoma management. The market for medical treatments has since increased and polypharmacy is now an accepted norm for glaucoma treatment. Surgical remedies for glaucoma have existed in a less pressured environment such that trabeculectomy, after four decades of slow evolution and complications, remains the most commonly performed type of glaucoma surgery worldwide. This ecosystem has begun to change in recent years. New surgical alternatives have arrived, reached a sizeable number and gained considerable traction as viable competitors to conventional glaucoma medical and surgical treatments. This raises important questions as to how these advances in glaucoma surgical options may affect the future landscape of glaucoma treatment. Has trabeculectomy already yielded some of its high ground? Why has trabeculectomy not been able to evolve more rapidly in response to new competitive pressures? If trabeculectomy has reached its evolutionary zenith are the newer alternatives any better? And, is it time to re-examine the conventional ‘medical before surgical’ approach to glaucoma? This article reviews the evidence for current surgical techniques available to patients with glaucoma.

Trabeculectomy

Trabeculectomy for the treatment of glaucoma is supported by a considerable body of evidence, accumulated over many years. However, sequential surveys of the American Glaucoma Society members and American Medicare insurance claims have demonstrated a recent decrease in the popularity of trabeculectomy across a variety of clinical scenarios.2 CIGTS demonstrated that over five years of follow-up, patients with a primary 5-fluorouracil (5FU) trabeculectomy achieved a lower mean intraocular pressure (IOP) than medically treated patients (1415mmHg versus 17-18mmHg).1 Patients with trabeculectomy needed cataract surgery more commonly, but after cataract extraction the two different treatment approaches resulted in similar visual acuities. The incidence of perioperative complications was high but few of these were serious or caused persistent visual loss.3 After 8 years of follow-up, visual field loss of ≥ 3dB of mean deviation (MD) was found in 21.3% and 25.5% of the surgical and medical patients, respectively.4 Patients with a baseline MD ≥ -10dB lost less visual field when treated initially with surgery. Patients with diabetes or African heritage lost more visual field when treated initially with surgery. Fluctuations of IOP were associated with less visual field loss in patients who were initially treated with surgery.5 Smokers treated with surgery had significantly higher postoperative IOPs, closer to those of medically treated patients. These results suggest a benefit for early trabeculectomy for certain patients presenting with moderately advanced glaucoma. CIGTS also reported early postoperative complications in 50% of eyes.

The five year risks of hypotony, blebitis and endophthalmitis were 1.5%, 1.5% and 1.1%, respectively. The British National Survey of Trabeculectomy reported one year data on 1,240 primary trabeculectomies, mainly performed without anti-metabolite.6 IOP was successfully reduced by more than a third without supplementary anti-glaucoma medication in 67% of cases. An IOP of less than 16mmHg without supplementary antiglaucoma medication was achieved in 55% of cases. Early post-operative complications were reported in 47% of cases. Complications later within the year were reported in 42% of cases including: loss of >1 line Snellen acuity including due to cataract in 19%, encapsulation of bleb in 3.4%, and endophthalmitis in 3 cases. Stead et al described their outcomes for trabeculectomy with mitomycin C (MMC) in 103 patients with a baseline MD ≥ -20dB.7 At 5 years an IOP of less than 16mmHg was achieved in 85% of cases; an IOP of less than 21mmHg was achieved in 96% of cases. Visual field MD scores were reported to have remained stable for individual patients. The Tube Versus Trabeculectomy Study (TVTS) reported five year data on eyes receiving trabeculectomy with MMC that had previously had cataract surgery or failed trabeculectomy.8,9 The TVTS found that 29% of trabeculectomy eyes required additional glaucoma surgery within five years. Of those not having further surgery, the mean IOP at 5 years was 12.6mmHg with use of a mean of 1.2 glaucoma medications. Sixty percent of patients had complications during the first 3 years of follow-up, 27% of which were serious enough to require re-operation and/or cause loss of ≥ 2 lines of Snellen acuity. PAN-AMERICA

41


REVIEW / Vis. Pan-Am. 2013;12(2):41-44

These trabeculectomy studies each have fundamental differences in the populations investigated and their use of anti-metabolites. However, they provide a picture of the strengths and limitations of trabeculectomy against which newer surgical techniques must be considered.

Aqueous shunt implants

Aqueous shunt implants drain aqueous from the eye to a bleb around a plate in the equatorial sub-Tenon’s space. The first such implant, the first generation Molteno implant was often associated with severe postoperative hypotony, such that aqueous shunts were relegated for use only in refractory glaucoma cases lacking other options. Newer implant designs still employ a long tube to avoid limbal drainage but the plate surface area and “valved” or “non-valved” designs have evolved. As surgical results have improved, the indications for these implants have increased to include their use in both primary and secondary glaucomas. The results of recent prospective, randomized, multicenter trials allow comparison between different implants types. Each implant study used similar definitions for failure, including an IOP > 21mmHg or > 18mmHg or an IOP not reduced > 20% from baseline, IOP < 5mmHg, additional glaucoma surgery or loss of light perception vision. A study of 92 patients with refractory glaucoma compared the valved Ahmed FP7 implant with the non-valved Molteno singleplate implant.10 At 2 years, the Molteno implant group had a greater percentage drop in IOP but also required more glaucoma medication to achieve pressure control compared to the Ahmed implant. The rates of failure were similar in each group. The valved Ahmed FP7 implant and non-valved Baerveldt 350mm2 have been compared in two studies, the Ahmed Baerveldt Comparison (ABC) Study and the Ahmed versus Baerveldt (AVB) Study, both of which reported one year follow-up data in 2011.11,12 Both studies reported lower mean IOP and less use of glaucoma medication in the Baerveldt groups but the Baerveldt groups also had a higher rate of post-operative complications and needed more interventions. The ABC study reported the rate of failure as non-statistically significantly higher in the Ahmed group. However, the AVB study defined an IOP > 18mmHg as failure and by this more stringent criterion reported the rate of failure to be 42

PAN-AMERICA

significantly higher than in the Ahmed group. The valved Ahmed S2 implant was compared against trabeculectomy with or without MMC in a randomized controlled trial of 123 patients with primary open angle and chronic angle closure glaucoma.13 Results were reported with a mean follow-up of 31 months showing a similar IOP, visual acuity and visual field outcomes. Use of glaucoma medications and the incidence of postoperative complications including failure were also non-significantly different between the two groups. The non-valved Baerveldt 350mm2 was compared against trabeculectomy with MMC in the Tube versus Trabeculectomy study.8,9 This study randomized 212 eyes that had previously had cataract surgery or failed trabeculectomy, 81% of which had primary open angle glaucoma. Five year data showed a non-statistically significantly lower mean IOP in the trabeculectomy group and a similar need for glaucoma medication. Post-operative complications and failure were both more common in the trabeculectomy group. Overall, the valved Ahmed implant probably remains the most popular implant used worldwide as it can provide early postoperative lowering of IOP, its valve mechanism helps to avoid hypotony and it is relatively simple to implant. However, study data support the use of the Baerveldt implant when lower longer-term IOPs and a reduced rate of encapsulation and failure are significant considerations. In terms of surgical complications, the placement of Baerveldt implants under the rectus muscles gives rise to a higher incidence of diplopia although this is rare and usually manageable with prisms or resolves with time. All tube devices carry a risk of corneal endothelial damage and corneal decompensation when placed in the anterior chamber angle. Tube placement in the sulcus or pars plana may reduce the risk to the cornea.

The Ex-PRESS mini shunt

The Express mini-shunt is a small, nonvalved stainless steel implant with an internal diameter of 50 microns. This tiny shunt is placed below a scleral flap near the limbus to drain aqueous from the anterior chamber to a limbal sub-conjunctival bleb as an alternative to trabeculectomy and iridotomy. Absence of an iridotomy has been suggested to cause less inflammation and avoid cataract formation. Anti-metabolites are used as for trabeculectomy to prevent scarring in


Spratt A & Lee RK. Surgical approaches to glaucoma treatment.

Table of best designed, largest studies described in this article. Surgical approach

Study design

Sample size

Mean follow-up time

Site of surgery

Destination for aqueous

Trabeculectomy

Randomized controlled trial

Various

Various

Superior limbus

Limbal drainage to subTenon’s space

Aqueous shunt implant

Randomized controlled trial

Various

Various

Any quadrant (most commonly superotemporal)

Equatorial drainage to subTenon’s space

Express shunt

Retrospective case control study

100

15 mo

Superior limbus under a scleral flap

Limbal drainage to subTenon’s space

Express shunt with phacoemulsification cataract surgery

Prospective case series

35

1 yr

Superior limbus under a scleral flap

Limbal drainage to subTenon’s space

Trabectome

Prospective case series (voluntary reporting)

101

2 yr

Nasal trabecular meshwork

Schlemm’s canal

Trabectome with phacoemulsification cataract surgery

Prospective case series (voluntary reporting)

304

21 mo

Nasal trabecular meshwork

Schlemm’s canal

Istent with phacoemulsification cataract surgery versus phacoemulsification cataract surgery alone

Randomized controlled trial

240

24 mo

Nasal trabecular meshwork

Schlemm’s canal

SOLX

Prospective case series

38

12 mo

Superior limbus

Suprachroidal space

the area around the scleral flap to allow for bleb formation. One small prospective study (n=24) and one sizeable retrospective study (n=100) have examined the outcomes of the Express mini-shunt. The prospective study used 0.05% MMC under the scleral flap and reported a 48% IOP reduction at 24 months with 5 cases of hypotony.14 The retrospective study age and sex matched Ex-PRESS cases with controls receiving trabeculectomy, all with 0.4mg/ ml MMC for 1 or 2 minutes.15 At 15 months Ex-PRESS and trabeculectomy cases had an IOP reduction of 55% and 47%, respectively, with a comparable reduced need for glaucoma medication. Time of surgery is similar in both groups so selection bias seems possible in this non-randomized study. Two prospective case series of combined Ex-PRESS mini shunt implantation with cataract extraction have reported their experience of a total of 61 eyes.16,17 One year data from each of these studies showed an IOP reduction of 22% and 27% with less need for glaucoma medication. Serious complications were rare but 17 eyes required bleb needling. No published studies have compared the effect of Ex-PRESS mini shunt implantation without cataract surgery against the effect of cataract surgery alone, thus confounding the results since cataract surgery has been shown to have an IOP lowering effect.

The Trabectome

The Trabectome uses ab interno electrocautery to ablate and open trabecular meshwork and the inner wall of Schlemm’s canal to create a direct pathway for aqueous to reach Schlemm’s canal. The Trabectome aims to reduce intraocular pressure without formation of a bleb. A prospective case series of 101 eyes with up to 30 months follow-up reported a 41% and 45% IOP reduction at 1 and 2 years, respectively.18 However, reporting of follow-up data was voluntary and is incomplete so as to prevent useful analysis of these data. Another prospective case series of 304 consecutive eyes reported the outcomes of combined Trabectome and cataract extraction in eyes with open angle glaucoma and clinically significant cataracts.19 At 21 months of follow-up, a 16.5% IOP reduction was reported. Complications were rare but 9% had an IOP spike after surgery. Loss to follow-up and the lack of a cataract extraction only control arm make it impossible to determine how effective the Trabectome procedure is at lowering IOP by itself without a contribution from cataract surgery. A randomised controlled trial of Trabectome versus trabeculectomy with MMC is underway.

The iStent

This small, non-valved, titanium implant forms an ab interno communication between Schlemm’s canal and the anterior chamber

to allow aqueous to bypass the trabecular meshwork. The iStent (Glaukos, Laguna Hills, CA) aims to reduce intraocular pressure without formation of a bleb. When tested in 21 human cadaveric eyes, a single iStent implant caused a 42% IOP reduction. Additional stents produced minimal further IOP reduction.20 An unmasked, multicenter, randomized, controlled trial of 240 eyes reported the outcomes of a single iStent implant with cataract surgery versus cataract surgery only, after washout of glaucoma medication.21 At 24 months of follow-up, the iStent with cataract surgery and cataract surgery only group had a 32% and 30% IOP reduction, respectively. At the same time-point, no statistically significant difference between the two groups in visual field loss or use of glaucoma medication was observed. Interestingly, a trend toward placing more than one iStent in an eye for IOP reduction is occurring, so it is unclear how many iStents can be or need to be placed in an eye to maximize IOP reduction.

The SOLX suprachoroidal implant

The SOLX Gold Shunt (SOLX, Boston, MA) forms an ab interno communication that allows aqueous to drain from the anterior chamber to the suprachoroidal space and exit the eye via the uveoscleral pathway. A prospective case series recruited 38 eyes with inclusion criteria of visual acuity worse PAN-AMERICA

43


REVIEW / Vis. Pan-Am. 2013;12(2):41-44

than “finger counting” and four quadrants of conjunctival scarring.22 With a mean follow-up time of 12 months, a 34% IOP reduction was observed. Complications included hyphema in 8 eyes and shunt removal secondary to complications from 10 eyes.

Conclusions

Trabeculectomy with anti-metabolite remains the global gold standard for primary surgical intervention against which new techniques need to be evaluated in well designed prospective clinical trials. Such comparative data does not yet exist.

REFERENCES 1. Lichter PR, Musch DC, Gillespie BW, et al; the CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001;108:1943-1953. 2. Ophthalmic Surg Lasers Imaging. 2011 May-Jun;42(3):202-8. doi: 10.3928/15428877-20110224-04. Practice preferences for glaucoma surgery: a survey of the American Glaucoma Society in 2008. Desai MA, Gedde SJ, Feuer WJ, Shi W, Chen PP, Parrish RK 2nd.

12. Christakis PG, Tsai JC, Zurakowski D, et al. The Ahmed Versus Baerveldt Study. Oneyear treatment outcomes. Ophthalmology. 2011;118:2180-2189. 13. Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003;136:464-470. 14. Dahan E, Carmichael TR. Implantation of a miniature glaucoma device under a scleral flap. J Glaucoma 2005;14:98–102.

3. Jampel HD, Musch DC, Gillespie BW, et al; the CIGTS Study Group. Perioperative complications of trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS). Am J Ophthalmol. 2005;140:16-22.

15. Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma 2007;16:14 –9.

4. Musch DC, Gillespie BW, Lichter PR, et al; the CIGTS Study Group. Visual field progression in the Collaborative Initial Glaucoma Treatment Study. Ophthalmology. 2009;116:200-207.

16. Traverso CE, De Feo F, Messas-Kaplan A, et al. Long term effect on IOP of a stainless steel glaucoma drainage implant (Ex-PRESS) in combined surgery with phacoemulsification. Br J Ophthalmol 2005;89:425–9.

5. Musch DC, Gillespie BW, Niziol LM, et al; the CIGTS Study Group. Intraocular pressure control and long-term visual field loss in the Collaborative Initial Glaucoma Treatment Study. Ophthalmology. 2011;118:1766-1773.

17. Rivier D, Roy S, Mermoud A. Ex-PRESS R-50 miniature glaucoma implant insertion under the conjunctiva combined with cataract extraction. J Cataract Refract Surg 2007;33:1946–52.

6. Eye (Lond). 2001 Aug;15(Pt 4):441-8. The National Survey of Trabeculectomy. II. Variations in operative technique and outcome.Edmunds B, Thompson JR, Salmon JF, Wormald RP.

18. Minckler D, Baerveldt G, Ramirez MA, et al. Clinical results with the Trabectome, a novel surgical device for treatment of openangle glaucoma. Trans Am Ophthalmol Soc 2006;104:40 –50.

7. Br J Ophthalmol 2011;95:960-965 Outcome of trabeculectomy with mitomycin C in patients with advanced glaucoma Stead, King

19. Francis BA, Minckler D, Dustin L, et al, Trabectome Study Group. Combined cataract extraction and trabeculotomy by the internal approach for coexisting cataract and openangle glaucoma: initial results. J Cataract Refract Surg 2008;34: 1096 –103.

8. Am J Ophthalmol. 2012 May;153(5):789803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group.

20. Bahler CK, Smedley GT, Zhou J, Johnson DH. Trabecular bypass stents decrease intraocular pressure in cultured human anterior segments. Am J Ophthalmol 2004;138:988 –94.

9. Am J Ophthalmol. 2012 May;153(5):804814.e1. doi: 10.1016/j.ajo.2011.10.024. Epub 2012 Jan 14. Postoperative complications in the Tube Versus Trabeculectomy (TVT) studyduring five years of follow-up. Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC; Tube Versus Trabeculectomy StudyGroup.

21. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j. jcrs.2012.03.025. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group.

10. 6. Nassiri N, Kamali G, Rahnavardi M, et al. Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: A comparative study. Am J Ophthalmol. 2010;149:893-902.

22. Melamed S, Ben Simon GJ, Goldenfeld M, Simon G. Efficacy and safety of gold micro shunt implantation to the supraciliary space in patients with glaucoma: a pilot study. Arch Ophthalmol 2009;127:264 –9.

11. Budenz DL, Barton K, Feuer WJ, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after one year of follow-up.

44

Ophthalmology. 2011;118:443-452.

PAN-AMERICA

The Tube versus Trabeculectomy Study results support increased use of the nonvalved 350mm2 Baerveldt implant in eyes that have had previous incisional surgery. Such patients and their doctors are now able to personalise the discussion of each operation’s disadvantages with the knowledge that longterm IOP outcomes are similar. The newer surgical approaches for glaucoma and the culture of innovation that accompanies them are encouraging for patients with glaucoma and the doctors who treat them. The main focus of these techniques firmly remains that of reducing intraocular pressure through bypassing presumed dysfunction in the trabecular route of aqueous outflow. Advances in manufacturing precision are likely to yield further refinements of microsurgical implants and tools with a similar therapeutic target and mechanism. Along these lines, encouraging initial experiences with novel ab interno devices such as the Aquesys (Aquesys, Irvine, CA) limbal sub-conjunctival stent implant, the Hydrus Aqueous Implant (Ivantis, Irvine, CA) Schlemm’s canal scaffold, and the CyPass (Transcend Medical, Menlo Park, CA) suprachoroidal shunt are being discussed at medical conferences. We anticipate the results of well designed studies that will be available for analysis and discussion in peerreviewed journals in the near future. For now, study designs and clinical results of the newer surgical alternatives to treat glaucoma have not delivered outcomes that convincingly merit a change in conventional clinical practice. The evidence suggests that trabeculectomy with anti-metabolite still deserves its place as the global gold standard for primary surgery to treat glaucoma, and is the operation to randomise against when investigating any new primary surgical approach. The newer surgical alternatives offer hope, but not evidence, that safe glaucoma treatment may not always require patients to consider lifelong medication, and often polypharmacy. There is no new data to suggest that the conventional ‘medical before surgical’ approach to glaucoma should be changed. Several well designed studies of novel surgical approaches are already underway which should clarify their role in the near future. Patients being treated outside of research studies should continue to receive treatment based on the best available medical evidence.


Liu TT et al. Ab interno trabeculectomy.

Ab Interno Trabeculectomy: a Comprehensive Review

Ting Ting Liu, MD, Paween Phuchantuk, MD, Samantha XY Wang, Ji Liu, MD, Tomas M. Grippo, MD Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut Funding: None Financial/propretary disclosure: None

INTRODUCTION

PURPOSE

Historical Perspectives

METHOD

A literature search in PubMed was performed on ab interno trabeculectomy with the Trabectome system, and clinical relevant information was reviewed and summarized.

RESULTS

Ab interno trabeculectomy with the Trabectome system on average lowered intraocular pressure (IOP) to the mid-teens, and decreased the number of required glaucoma medications. Greater preoperative IOP correlated to a greater percent reduction in IOP. The success rates varied among studies, and the definition of success differed by authors. Intraoperative blood reflux was found in nearly all cases. Incidences of early hypotony and IOP spikes were low. No cases of endophthalmitis, wound leak, aqueous misdirection, choroidal hemorrhage or effusions, and irreversible visual acuity decrease (≥2 Snellen lines) have been reported. Available studies had a significant amount of data overlap. Only limited data on long-term results was available. There was no randomized controlled trial to date.

CONCLUSIONS

Ab interno trabeculectomy with the Trabectome system is an effective and safe surgical approach for patients with various types of open angle glaucoma. On average, the procedure at least in the short term lowers IOP to the mid teens regardless of preoperative IOP with or without the aid of topical medications.

Tomas M. Grippo, MD, Department of Ophthalmology and Visual Science, Yale University School of Medicine, 40 Temple Street, New Haven, Connecticut. E-mail: tomas.grippo@yale.edu Date of submission: 12/3/2013 y Date of Approval: 09/04/2013

ABSTRACT To summarize the original literature on ab interno trabeculectomy with the Trabectome system and to review its efficacy and safety in the treatment of glaucoma.

Corresponding author

The first ab interno trabeculectomy was a blind surgical procedure of the trabecular meshwork known as “incision of the angle formed between the iris and the cornea” described by the Italian ophthalmologist, Carlo de Vincentiis in 1893.1 This technique was forgotten until 1936, when Otto Barkan visualized the anterior chamber with a surgical contact glass and performed a 90-120 degree superficial incision of the trabecular meshwork with a tapered blade. This new surgical approach was named “goniotomy,” meaning cutting the angle.2 This procedure attained success in the treatment of congenital glaucoma, but yielded relatively poor results in adults secondary to scarring.3,4 Although intraocular pressure (IOP) no longer defines glaucoma, it remains the only modifiable factor to decrease both the risk of disease onset and progression. Numerous studies have demonstrated that lowering IOP protects against glaucomatous optic nerve damage and visual field loss in all types of glaucoma and glaucoma suspect patients.5-9 Trabeculectomy and glaucoma drainage devices remain the standard in the surgical treatment of glaucoma, with proven efficacy through randomized controlled trials.9,10 However, the significant rates of complications and the invasiveness of these procedures have been inciting the research and development of new alternatives in glaucoma surgery termed micro-invasive glaucoma surgery (MIGS). Ideally MIGS procedures would have 5 preferred qualities: 1) conjunctivasparing ab interno microincision, 2) minimal trauma to target tissue, 3) efficacy, 4) high safety profile, and 5) rapid recovery time with minimal impact on quality of life.11 Ab interno trabeculectomy with the Trabectome system

(Trabectome, Neomedix, Tustin, CA, USA) is one of MIGs that has been gaining increasing interest and utilization over the last couple of years.

Rationale for Ab Interno Trabeculectomy

The highest point of resistance in the conventional outflow pathway resides in the juxtacanalicular component of the trabecular meshwork.12 Ab interno trabeculectomy aims to remove the trabecular meshwork exposing Schlemm’s canal, resulting in a direct communication between the lumen of Schlemm’s canal and the anterior chamber, enhancing physiological aqueous outflow and reducing IOP.13,14 Due to ease of access and visibility through a temporal clear corneal incision, the nasal quadrants are the most common sites ablated during this procedure. The nasal trabecular meshwork also coincides with the highest concentrated area of collector channels as shown by spectral domain ocular coherence tomography (SD-OCT) in both cadaveric and living human eyes.15-17 Prior to the invention of Trabectome, laser goniopuncture and goniocurettage were variations of ab interno trabeculectomy that showed potential results from limited data.18-20

The Trabectome System

A new instrument, the Trabectome, employs high-frequency microelectrocautery with simultaneous infusion and aspiration, aiming to selectively remove the trabecular meshwork and the inner wall of Schlemm’s canal without structurally damaging canal outer wall or adjacent angle structures.14,21 The Trabectome device has 3 major components: 1) a mobile stand with a gravityfeed bottle for balanced salt solution infusion, 2) a single-use intraocular handpiece with an electrosurgical ablation unit and automated irritation aspiration ports, and 3) a foot-pedal PAN-AMERICA

45


REVIEW / Vis. Pan-Am. 2013;12(2):45-50

a. Handpiece b. Power, IA Line c. Irrigation/Aspiration Unit d. High Frequency Generator e. Clean Tray f. Main Stand g. Foot Control

Irrigation Port

Protectivo Footplate Aspiration Port Returm Electrode Active Electrode

Figure 1. The Trabectome System (Permission by Neomedix, Tustin, CA, USA)

Figure 2: Gonioscopic view of the Trabectome tip insertion into Schlemm’s canal

with step-wise control of irrigation, aspiration and ablation (Figure 1). The intraocular handpiece contains a 19-gauge gravity infusion sleeve, a 25-gauge aspiration port, and an ablation unit at the tip. The surgical tip has a triangular pointed footplate shaped in 90° bent to the shaft. Coated by multi-layered proprietary polymer with thermal stability at 500° C, the footplate is specially designed to facilitate insertion into Schlemm’s canal by lifting the TM with a slight stretch. The wellinsulated hook design feeds trabecular and juxtacanalicular tissue into the cautery while providing thermal and mechanical protection to adjacent structures gliding along within the canal. The ablation is achieved through electrode couplings by high frequency (550 kHz) electrocautery generator, modified 800EU unit from Aaron/Bovie (St. Petersburg, FL). High-energy bursts disrupt and disintegrate target tissue rather than thermally destruct. The aspiration port removes debris 0.3 mm from ablation tip, and irrigation pressurizes the eye and dissipates heat energy.14,22,23

Surgical Procedure

With slight variations in techniques among surgeons, the surgical procedure is briefly described as follows. The patient is placed on the operating gurney supine and routinely prepared and draped. If combined with cataract surgery, a side-port incision is first created, followed by the injection of non-preserved lidocaine. The Trabectome procedure begins with a 1.7 to 1.8 mm temporal corneal incision with internal flare. The patient’s head is tilted roughly 45 degrees away from the surgeon and the microscope is tilted 45 degrees towards the surgeon to optimize gonioscopic view of the angle. The handpiece is then inserted into the anterior chamber under continuous irrigation to maintain anterior chamber depth.

46

PAN-AMERICA

A gonioscopic lens (modified Swan-Jacob goniolens) is used to visualize the target nasal TM as the Trabectome tip is advanced into the angle. The pointed tip of the footplate is inserted from below through the trabecular meshwork into Schlemm’s canal just anterior to the scleral spur (Figure 2). Once correct placement of the footplate is noted, the foot pedal is used to initiate aspiration and electrocautery as the surgeon slowly advances the instrument along the meshwork in a counterclockwise and then a clockwise direction or vice versa to remove a strip of the trabecular meshwork and inner wall of Schlemm’s canal. Typical ablation arc is 90 to 120 degrees total, and power is titrated from a initial setting of 0.7 to 0.8 W depending on the desire to ablate a wider strip of the trabecular meshwork or to minimize charring of the tissue.24,25 When ablation is complete, the handpiece is removed from the anterior chamber; cataract extraction and intraocular lens implantation can be done using the surgeon’s preferred technique. Postoperative care varies according to clinical presentation, but routinely includes topical steroid, topical antibiotics, and 1% to 2% pilocarpine over several weeks to months to enhance aqueous outflow and to minimize the development of peripheral anterior synechiae.14,24

Histopathology

Quantitative light microscopy studies of healthy human eyes showed age-related changes of the trabecular meshwork, including progressive trabecular thickening, giant vacuoles in the endothelial lining of Schlemm’s canal, and increased deposition of electron dense plaques.26 Morphologically, older adult tissues have thicker trabecular beams with less elastic tissue than younger patients. After goniotomy in children, the high elasticity of trabecular tissues keep the incised cleft stretched open. In contrast, the reduced tissue elasticity through aging leads to reapproximation of the severed incision ends and cleft closing from fibrosis.27 In an in vitro study of fresh donor corneoscleral rims post Trabectome treatment, histological examination of the specimens showed full-thickness disruption of the trabecular meshwork and Schlemm’s canal inner wall with open cleft. By comparison, simulated goniotomy treated samples showed full-thickness disruption of the trabecular meshwork with overlap of the severed flaps that can potentially scar together to close the cleft.25,28


Liu TT et al. Ab interno trabeculectomy.

Table 1. Preoperative and postoperative IOP and medication use in all cases of Trabectome surgerya

Pre-op IOP (n)

Minckler 2006

Francis 2008

Minckler 2008b

Jea 2012

Ting 2012b

27.6 ± 7.2 (101)

20 ± 6.3 (304)

23.3 (1127)

28.1 ± 8.6 (115)

23.5 (825)

16.4 ± 2.2 (37)

15.5 ± 2.9 (34)

16.0 (147)

17.4 ± 5.9 (34)

16.1 (635)

c

Post-op IOP 12 months 18 months

15.9 ± 2.0 (30)

16.7 ± 3.5 (7)

16.0 (87)

17 ± 4.6 (30)

----

24 months

15.2 ± 2.4 (18)

----

16.4 (50)

15.9 ± 4.5 (24)

----

30 months

16.3 ± 3.3 (11)

----

16.6 (42)

16.6 ± 7.7 (22)

----

48 months

----

----

16.1 ± 1.9 (20)

----

----

60 months

----

----

17.5 ± 0.7 (2)

----

----

Pre-op Meds

----

2.7±1.1

2.9

3.3 ± 1.3

2.6

Post-op Meds 12 months

----

1.4±1.3

1.5

1.8 ± 1.3

1.9

18 months

----

1.4±1.3c

1.2

2.0 ± 1.5

----

24 months

----

----

1.2

2.2 ± 1.6

----

30 months

----

----

1.3

2.3 ± 1.8

----

48 months

----

----

0.9

----

----

60 months

----

----

0.5

----

----

Abbreviations: IOP, intraocular pressure; Meds, number of medications used; ----, not available a: All cases included, Trabectome surgery alone or in combination with other surgeries b: Recalculated mean from subgroup means, no data available to recalculate SD c: Data at 21 months instead of 18 months

METHODS

A literature review inclusive of all articles searchable in PubMed up to March 2013 was performed to assess the efficacy and safety of ab interno trabeculectomy with the Trabectome system in the treatment of glaucoma. Preoperative and postoperative IOP, changes in glaucoma medication reliance, surgical success and its definitions, adverse effects as well as secondary surgeries were summarized and analyzed.

RESULTS

Among all the articles related to Trabectome generated through PubMed search, 8 were found to be primary studies reporting original clinical outcomes of Trabectome surgeries. There was no randomized controlled trial to date. Two of the 8 articles, by Nguyen and by Filippopoulos, were excluded from our review since the data was inclusively published by Minckler et al in 2008.23,29,30 The remaining 6 studies were described in synopsis, and the clinical results from each study except the pilot were summarized into 3 tables. Table 1 reported the changes in intraocular pressure and medication use after all cases of Trabectome surgery, alone or in combination with other surgeries. Table 2 summarized the success rates along with their definitions by each author. Table 3 tabulated the postoperative adverse events and late complications.

The pilot study for Trabectome surgery was conducted by Minckler at the Codet Eye Institute in Tijuana, Mexico, between 2003 and 2004.24 Thirty-seven adult Hispanic and Caucasian patients with uncontrolled glaucoma, with or without previous surgery underwent Trabectome surgery only regardless of their lens status. Inclusion criteria consisted of uncontrolled glaucoma on maximal available or tolerated medications, age above 18 years, open angles (Shaffer Grade II or above), and phakic or pseudophakic eyes. Exclusion criteria included vision less than hand motion, compromised gonioscopic view, anatomically confusing angle, neovascularization of iris or angle, and significant medical conditions precluding surgery. An overall 40% IOP reduction from baseline and a decrease in adjunct medications was observed at 12 month follow up visits (n = 15). After approval by the US Food and Drug Administration in April 2004, the clinical use of Trabectome in the United States began in January 2006. Minckler et al expanded the original series of 37 cases to a prospective multicenter study of 101 cases and published the updated results in 2006.14 Changes in inclusion criteria of new participants were removing the age limit, and open angle defined as Shaffer grade I or above. Exclusion criteria remained the same. In 2008, Francis et al reported the short-term results of phacoemulsification

combined with Trabectome in a prospective interventional case series.31 The series included 304 cases from all surgical centers in the Trabectome Study Group without exclusion or inclusion criteria. Minckler et al in 2008 reported the updated results up to 60 months from the ongoing Trabectome case series, expanding the data to 1127 surgeries performed at 46 different glaucoma centers since January 2006 in United States, Canada, Mexico, and Japan.23 Among these, 336 were Trabectome-phacoemulsification surgeries, 15 cases were other combined surgeries that included goniosynechalysis, tube shunt, penetrating keratoplasty, bleb revision, and endocyclophotocoagulation; the remaining were Trabectome only surgeries. Patient age ranged from 3 days to 96 years, with a mean of 69 years (SD = 15). A variety of glaucoma types were indicated, including primary open angle, pseudoexfoliation, juvenile idiopathic arthritis, steroid-induced, pigment dispersion, and uveitis-related. Fifty-three percent of the patients had prior ocular surgeries or laser. A comparative retrospective cohort study emerged in 2012 that compared the effect of Trabectome surgery with trabeculectomy.31 The study reported 114 Trabectome cases and 102 trabeculectomy cases performed by 2 surgeons over a four-year period. All subjects were age 40 or older, with uncontrolled open angle glaucoma and no prior surgeries. PAN-AMERICA

47


REVIEW / Vis. Pan-Am. 2013;12(2):45-50 Table 2. Success Rates Success Rate (n)

Definition

12 months

18 months

24 months

48 months

Minckler 2006

IOP reduction 30% or greater, or IOP ≤ 21 mmHg with or without medications and no repeat surgeries

79% (37)

74% (30)

71% (18)

----

Francis 2008

A decrease in IOP of 20% from baseline or a decrease in glaucoma medications, no additional medications or glaucoma surgery

64% (34)

52%* (7)

----

----

75%*(147)

72%* (87)

70%* (50)

69%* (20)

68%*(102)

67%* (67)

65%* (46)

61%* (20)

90%* (45)

87%* (20)

87%* (4)

----

36% (34)

23%* (30)

22% (24)

18%* (22)

63% (293)

----

----

----

91% (247)

----

----

----

Minckler 2008 T only

IOP ≤21 mmHg or reduced ≥ 20% below baseline on 2 consecutive visits after 2 weeks follow-up and no subsequent surgery

T-CE

Jea 2012

No additional glaucoma surgery or loss of light perception vision, IOP ≤ 21 mmHg and reduction ≥ 20% below baseline on 2 consecutive follow-up visits after 1 month

Ting 2012 POAG T POAG T-CE XFG T

No secondary surgery, IOP less than 21 mmHg and a greater than 20% reduction from baseline on the last 2 consecutive follow-up visits after 3 months

XFG T-CE

79% (53)

----

----

----

87% (42)

----

----

----

Abbreviations: IOP, intraocular pressure; T, Trabectome; T-CE, Trabectome with cataract extraction; POAG, primary open angle glaucoma; XFG, Pseudoexfoliation glaucoma; ----, not available * Estimated reading from Kaplan-Meier plots

In 2012, Ting et al reported the outcomes of 825 cases of pseudoexfoliation glaucoma (XFG) versus primary open-angle glaucoma (POAG) after Trabectome alone or in combination with phacoemulsification.22 The data were obtained from the Trabectome Study Group inclusive from May 2003 to May 2011. All cases included in the study had a minimum follow-up of one year. Exclusion criteria were missing preoperative IOP and previous incisional procedures. Reported IOP reduction at 12 months among all Trabectome cases, alone or combined, ranged from 22% to 40%.4,22,23,31,32 Greater preoperative IOP correlated to a greater percent reduction in IOP. However, the postoperative IOP remained consistently in the mid-teens, ranging around 15 mm Hg to

17 mm Hg across all studies analyzed (Table1, Figure 3). A reduction of glaucoma medications was maintained throughout the follow-up periods in all studies, with reported 25% to 48% decrease one-year post surgery. There was great disparity (2.9 to 43.5%) in secondary surgeries among the studies (Table 3). The variability was likely a result of patient selection, differences in follow-up time, preoperative IOP, and whether or not they had prior surgeries. Similar disparity was found in success rates (Table 2). Aside from common variables, the heterogeneity on the definitions of success and failure was a major hindrance in the comparison and evaluation of the clinical results. Furthermore, long-term results of Trabectome surgery were limited, with only 20 cases beyond 48 months, and 2 beyond 60 months (Table1, Table 2). Complications were comparable between combined and Trabectome-only procedures.31 The most common complication for Trabectome surgery is intraoperative blood reflux, with a reported incidence of 78% to 100% (Table 3). The subsequent hyphema typically resolved after a few days, and a consistent correlation with

Table 3. Postoperative Adverse Events and Late Complications n (%) Total cases Secondary surgery Intraoperative blood reflux

Minckler 2006

Francis 2008

Minckler 2008

Jea 2012

Ting 2012

101

304

1127

115

825

9 (8.9%)

9 (2.9%)

113 (10.0%)

50 (43.5%)

190 (23.0%)

101 (100%)

238 (78.3%)

874 (78.0%)

115 (100%)

692 (83.9%)

Hypotony day 1

1 (1.0%)

4 (1.3%)

17 (1.5%)

0

5 (0.6%)

IOP spike day 1

4 (3.9%)

26 (8.6%)

65 (5.8%)

4 (3.5%)

48 (5.8%)

Cyclodialysis cleft

----

0

----

1 (0.9%)

----

Infection

----

0

0

0

0

Would leaks

----

0

0

0

0

Choroidals

----

0

0

0

0

Abbreviations: IOP, Intraocular Pressure; ----, not reported

48

PAN-AMERICA


Liu TT et al. Ab interno trabeculectomy.

30

Pre op

IOP (mm Hg)

25 20

22%

31%

31%

Minckler 2008

Ting 2012

40%

38%

% reduction Post op

15 10 5 0 Francis 2008

Minckler 2006

IOP elevation was not seen.23 Low incidences of early hypotony (1 to 1.5%) and early IOP spike (3.5 to 8.6%) were found in all studies. One case of cyclodialysis cleft has been reported. Other complications reported included minor iris and lens capsule injuries from the Trabectome tip with an incidence of less than 2%.31 No cases of endophthalmitis, wound leak, aqueous misdirection, choroidal effusions or hemorrhage, or irreversible visual acuity decrease (â&#x2030;Ľ2 Snellen lines) have been reported.14,22,23,31,32

DISCUSSION

The analysis of the available studies on Trabectome surgery was limited. Direct comparison of the clinical results was difficult as they were secondary to variable definitions of success and there was a lack of homogeneity in the cases included. There was also a great amount of overlap of cases reported among the studies currently published. All surgeons new to Trabectome surgery after January 2006 required mandatory training and reporting of their initial 20 surgeries with a 1-year followup. Data were collected on standardized reporting forms that became the Trabectome Study Group database, which is continually updated and is available to all surgeon participants. Data submission after one year is encouraged but voluntary, which likely contributes to the lack of long-term clinical results.22,32 All authors of the articles reviewed above either used the Trabectome Study Group data and/or were participating surgeons. Since this database consisted largely of the first 20 cases of new users, results may not be representative given the intrinsic learning curve associated with any new procedure. Surgical results may improve as the surgeons become more proficient. In comparison to the gold standardtrabeculectomy or tube shunt surgeries, current

Jea 2012

Figure 3: Preoperative IOP and postoperative IOP at 12 months follow-up

literature suggests the Trabectome system to be inferior in IOP reduction and success rate. As reported by Jea et al in a comparative retrospective cohort study of Trabectome vs. trabeculectomy, the Trabectome group had a 43.5% reduction from preoperative IOP versus 61.3% in the trabeculectomy group at 2-year follow-up, and the success rates were 22.4% and 76.1% respectively. The Trabectome group has a higher mean IOP and greater need for supplemental glaucoma medications at all time points. More patients received additional glaucoma procedures after Trabectome surgeries (43.5%) than after trabeculectomy surgeries (10.8 %).31 The success of trabeculectomy and tube shunt surgeries, however, is burdened with significant complication rates. In the direct comparison of Trabectome vs. trabeculectomy by the same 2 surgeons, Jea et al published complication rate of 4.3% with exclusion of intraoperative blood reflux in the Trabectome group to be significantly lower than 35.5% in the trabeculectomy group.31 In major clinical trials of trabeculectomy and tube shunt surgeries, postoperative complications such as wound leak, shallow or flat anterior chamber, persistent diplopia, hypotony, infection, choroidal effusion and hemorrhage were found to be 50 to 57% and 34 % respectively.33,34 While no serious complications associated with reoperation and vision loss was reported in the Trabectome results, 22% and 20% were found in tube shunt and trabeculectomy respectively.33 One Trabectome complication not observed in the list of studies summarized, but reported in literature, is postoperative delayed-onset hyphema.35,36 A retrospective case series of 262 Trabectome surgeries reported delayed-onset symptomatic hyphema in 4.6% of the cases in the absence of trauma or surgery.36 Median time of onset was 8.6 PAN-AMERICA

49


REVIEW / Vis. Pan-Am. 2013;12(2):45-50

months after surgery, ranging from 2 to 31 months. Sleeping on the surgical side was found to be the most common characteristic. The proposed mechanisms are sudden decompression of the globe after ocular compression or exertion-related increase in episcleral venous pressure. Among glaucoma patients requiring surgical intervention, many might not be ideal candidates for trabeculectomy or tube shunt surgeries for varies reasons, including surgical invasiveness and intensive postoperative care. Patients with obesity, uncontrolled hypertension, and very broad necks have increased risk of choroidal hemorrhage from intraoperative positive pressure and postoperative hypotony.37 Added risk of hypotony maculopathy is found with myopia. Bleb-related complications such as encapsulation, leakage and infection are especially problematic in patients with ocular surface disease such as ocular cicatrical pemphigoid or chronic blepharoconjunctivitis.38 Moreover, proper sclera flap in traditional trabeculectomy with antimetabolite might be not possible in patients with abnormally thin sclera due to

collagen disease.39,40 In these cases, not only is Trabectome surgery a favorable alternative, with ab interno approach, a cardinal feature of MIGS procedures, the conjunctiva is also spared for future surgical intervention. In one study that compared 34 eyes undergoing trabeculectomy following a failed Trabectome to 42 eyes undergoing trabeculectomy as a primary surgical procedure, no difference was found in IOP outcome or success rates between the two groups.41 The short-term results on Trabectome surgery continue to grow through the Trabectome Study Group as more surgeons utilize the new procedure. However, the long-term data is still quite lacking. Current literature supports the use of Trabectome in various types of open angle glaucoma. Good candidates are patients with open angle, normal episcleral venous pressure, identifiable angle anatomy, and clear cornea allowing visualization of the angle.22,31 Given its effectiveness, but only moderate IOP lowering potential, Trabectome surgery is better suited for patients who would stabilize with target pressures in the mid teens or higher. In addition, Trabectome surgery

may especially be valuable in patients with exceedingly elevated IOP but little or no glaucomatous damage, who in the past would have undergone more invasive interventions.

CONCLUSIONS

Ab interno trabeculectomy with the Trabectome system is an effective and safe surgical approach for patients with various types of open angle glaucoma. On average, the procedure at least in the short term lowers IOP to the mid teens regardless of preoperative IOP with or without the aid of topical medications. It may be an alternative for patients who are poor candidates for traditional trabeculectomy or tube shunt surgeries; in addition, subsequent trabeculectomy can be performed with equal efficacy post Trabectome surgery. Long-term data is currently lacking, and no randomized controlled trial is available. Well-designed randomized clinical trials with adequate longterm follow-up comparing Trabectome surgery to other surgeries will shed more light to its role within our current glaucoma treatment algorithm. Moreover, an advocacy towards standardizing the definition of success and failure would enhance future studies.

REFERENCE 1. C DV. Incisione dell’angolo irideo nel glaucoma. Ann Ottal 1894;22:540-555. 2. Barkan O. Goniotomy for the Relief of Congenital Glaucoma. The British journal of ophthalmology. Sep 1948;32(9):701-728. 3. Chihara E, Nishida A, Kodo M, et al. Trabeculotomy ab externo: an alternative treatment in adult patients with primary open-angle glaucoma. Ophthalmic surgery. Nov 1993;24(11):735-739. 4. Barkan O. Surgery of congenital glaucoma; review of 196 eyes operated by goniotomy. American journal of ophthalmology. Nov 1953;36(11):1523-1534. 5. The advanced glaucoma intervention study, 6: effect of cataract on visual field and visual acuity. The AGIS Investigators. Archives of ophthalmology. Dec 2000;118(12):1639-1652. 6. Anderson DR, Normal Tension Glaucoma S. Collaborative normal tension glaucoma study. Current opinion in ophthalmology. Apr 2003;14(2):86-90. 7. Leske MC, Heijl A, Hyman L, et al. Predictors of long-term progression in the early manifest glaucoma trial. Ophthalmology. Nov 2007;114(11):1965-1972. 8. Gordon MO, Beiser JA, Brandt JD, et al. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Archives of ophthalmology. Jun 2002;120(6):714-720; discussion 829-730. 9. Tsai JC, Johnson CC, Dietrich MS. The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma: a single-surgeon comparison of outcome. Ophthalmology. Sep 2003;110(9):1814-1821. 10. Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. American journal of ophthalmology. May 2012;153(5):789-803 e782. 11. Saheb H, Ahmed IIK. Micro-invasive glaucoma surgery: current perspectives and future directions. Current opinion in ophthalmology. Mar 2012;23(2):96-104. 12. Grant WM. Experimental aqueous perfusion in enucleated human eyes. Archives of ophthalmology. Jun 1963;69:783-801. 13. Hetland-Eriksen J, Odberg T. Experimental tonography on enucleated human eyes. I. The validity of Grant’s tonography formula. Investigative ophthalmology. Mar 1975;14(3):199-204. 14. Minckler D, Baerveldt G, Ramirez MA, et al. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma. Transactions of the American Ophthalmological Society. 2006;104:40-50. 15. Ferrari E, Ortolani F, Petrelli L, et al. Ab interno trabecu-

50

PAN-AMERICA

lectomy: ultrastructural evidence and early tissue response in a human eye. Journal of cataract and refractive surgery. Oct 2007;33(10):1750-1753. 16. Kagemann L, Wollstein G, Ishikawa H, et al. Identification and assessment of Schlemm’s canal by spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. Aug 2010;51(8):4054-4059. 17. Kagemann L, Wollstein G, Ishikawa H, et al. 3D visualization of aqueous humor outflow structures in-situ in humans. Experimental eye research. Sep 2011;93(3):308-315. 18. Jacobi PC, Dietlein TS, Krieglstein GK. Goniocurettage for removing trabecular meshwork: clinical results of a new surgical technique in advanced chronic open-angle glaucoma. American journal of ophthalmology. May 1999;127(5):505-510. 19. Ferrari E, Bandello F, Roman-Pognuz D, Menchini F. Combined clear corneal phacoemulsification and ab interno trabeculectomy: three-year case series. Journal of cataract and refractive surgery. Sep 2005;31(9):1783-1788. 20. Hill RA, Baerveldt G, Ozler SA, Pickford M, Profeta GA, Berns MW. Laser trabecular ablation (LTA). Lasers in surgery and medicine. 1991;11(4):341-346. 21. Francis BA, See RF, Rao NA, Minckler DS, Baerveldt G. Ab interno trabeculectomy: Development of a novel device (Trabectome (TM)) and surgery for open-angle glaucoma. Journal of glaucoma. Feb 2006;15(1):68-73. 22. Ting JLM, Damji KF, Stiles MC, Grp TS. Ab interno trabeculectomy: Outcomes in exfoliation versus primary open-angle glaucoma. Journal of cataract and refractive surgery. Feb 2012;38(2):315-323. 23. Minckler D, Mosaed S, Dustin L, Ms BF. Trabectome (trabeculectomy-internal approach): additional experience and extended follow-up. Transactions of the American Ophthalmological Society. 2008;106:149-159; discussion 159-160. 24. Minckler DS, Baerveldt G, Alfaro MR, Francis BA. Clinical results with the Trabectome for treatment of open-angle glaucoma. Ophthalmology. Jun 2005;112(6):962-967. 25. Francis BA, See RF, Rao NA, Minckler DS, Baerveldt G. Ab interno trabeculectomy: development of a novel device (Trabectome) and surgery for open-angle glaucoma. Journal of glaucoma. Feb 2006;15(1):68-73. 26. Kagemann L, Wollstein G, Ishikawa H, et al. Visualization of the Conventional Outflow Pathway in the Living Human Eye. Ophthalmology. Jun 7 2012. 27. McMenamin PG, Lee WR, Aitken DA. Age-related changes in the human outflow apparatus. Ophthalmology. Feb 1986;93(2):194-209. 28. Horstmann HJ, Rohen JW, Sames K. Age-related changes in the

composition of proteins in the trabecular meshwork of the human eye. Mechanisms of ageing and development. Feb 1983;21(2):121-136. 29. Nguyen QH. Trabectome: a novel approach to angle surgery in the treatment of glaucoma. International ophthalmology clinics. Fall 2008;48(4):65-72. 30. Filippopoulos T, Rhee DJ. Novel surgical procedures in glaucoma: advances in penetrating glaucoma surgery. Current opinion in ophthalmology. Mar 2008;19(2):149-154. 31. Jea SY, Francis BA, Vakili G, Filippopoulos T, Rhee DJ. Ab interno trabeculectomy versus trabeculectomy for open-angle glaucoma. Ophthalmology. Jan 2012;119(1):36-42. 32. Francis BA, Minckler D, Dustin L, et al. Combined cataract extraction and trabeculotomy by the internal approach for coexisting cataract and open-angle glaucoma: initial results. Journal of cataract and refractive surgery. Jul 2008;34(7):1096-1103. 33. Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC. Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up. American journal of ophthalmology. Jan 2007;143(1):23-31. 34. Jampel HD, Musch DC, Gillespie BW, et al. Perioperative complications of trabeculectomy in the collaborative initial glaucoma treatment study (CIGTS). American journal of ophthalmology. Jul 2005;140(1):16-22. 35. Ahuja Y, Malihi M, Sit AJ. Delayed-onset symptomatic hyphema after ab interno trabeculotomy surgery. American journal of ophthalmology. Sep 2012;154(3):476-480 e472. 36. Knape RM, Smith MF. Anterior Chamber Blood Reflux During Trabeculectomy in an Eye With Previous Trabectome Surgery. Journal of glaucoma. Sep 2010;19(7):499-500. 37. Yap YC, Woo WW, Kathirgamanathan T, Kosmin A, Faye B, Kodati S. Variation of blood pressure during topical phacoemulsification. Eye (Lond). Feb 2009;23(2):416-420. 38. Sagara H, Iida T, Suzuki K, Fujiwara T, Koizumi H, Yago K. Sodium hyaluronate eye drops prevent late-onset bleb leakage after trabeculectomy with mitomycin C. Eye (Lond). Apr 2008;22(4):507514. 39. Fourman S. Scleritis after glaucoma filtering surgery with mitomycin C. Ophthalmology. Oct 1995;102(10):1569-1571. 40. Akova YA, Koc F, Yalvac I, Duman S. Scleromalacia following trabeculectomy with intraoperative mitomycin C. European journal of ophthalmology. Jan-Mar 1999;9(1):63-65. 41. Jea SY, Mosaed S, Vold SD, Rhee DJ. Effect of a failed trabectome on subsequent trabeculectomy. Journal of glaucoma. Feb 2012;21(2):71-75.


Fawzi AA et al. Severe serous macular detachment in hypotony.

Severe Serous Macular Detachment in the setting of hypotony and Complex Hypercoagulability Syndrome Amani A. Fawzi, M.D.,1 Vikas Chopra, M.D.,2 Brian A. Francis, M.D.,2

Corresponding Author:

1. Northwestern University Department of Ophthalmology, Chicago, IL 2. Doheny Eye Institute, University of Southern California, Keck School of Medicine, Los Angeles, CA

Brian Francis, MD, MS Doheny Eye Institute, 1450 San Pablo Street, Los Angeles, CA 90033. email: bfrancis@usc.edu tel : (323) 442-6454, fax: (323)442-6412

Funding: None Financial/Proprietary interest: None

Date of submission: 12/3/2013 y Date of Approval: 09/04/2013

Abstract

We report the occurrence and management of a massive serous detachment of the macula, which followed trabeculectomy and lowering of the intraocular pressure (IOP) in a patient with central retinal vein occlusion (CRVO) and a previously undiagnosed complex coagulopathy with elevated plasma fibrinogen and homocysteine levels, as well as prothrombin 20210 and factor V Leiden mutations. Our case illustrates prompt resolution of the serous detachment with elevation of the IOP, and acute recurrence of the detachment following subsequent recurrence of hypotony after aqueous tube shunt surgery. Residual cystoid macular edema (CME) in the right eye, as well as hemiretinal vein occlusion with serous macular detachment and CME in the fellow left eye responded to bevacizumab. The occurrence of severe macular edema following lowering of intraocular pressure may warrant further evaluation for possible underlying venous occlusive disease or systemic coagulopathy. Key words: macula, detachment, glaucoma, hypotony, coagulopathy.

Case report

A 26 year-old Caucasian male presented with a serous macular detachment in the setting of a prior central retinal vein occlusion (CRVO) of the right eye. His prior treatment history consisted of the following: he had previously received intravitreal triamcinolone (IVTA) for macular edema and developed steroid-induced glaucoma. His glaucoma was poorly controlled despite maximum tolerated medical therapy (latanaprost 0.05%, dorzolamide 2%-timolol 0.5% and brimonidine purite 0.15%) and he underwent trabeculectomy surgery. Postoperatively, his visual acuity declined from 20/40 to 20/200 and he underwent cataract extraction with intraocular lens implantation. After the cataract surgery, massive subretinal macular fluid developed and did not respond to additional IVTA. The patient then presented to us for a second opinion regarding further management. Past medical history was significant for severe hypertension and end- stage renal disease secondary to glomerulonephritis. The patient had undergone a successful cadeveric renal transplant five years prior and was therefore on immunosuppressive medications including prednisone 20 mg/day, sirolimus (Rapamune, Wyeth) and mycophenolate mofetil (Cellcept, Roche). In addition he was on epoetin alpha (Procrit, Ortho biotech), omeprazole (Prilosec, Procter and Gamble), furosemide, hydralazine, metoprolol and minoxidil. On initial presentation, his visual acuity was 20/800 in the right and 20/20 in the left eye. There was a functioning bleb in the right eye,

Figure 1A: Baseline color fundus photograph of the right eye at presentation showing massive serous elevation of the macula, dilated tortuous veins with optic nerve head hyperemia and no evidence of retinal ischemia or neovascularization.

PAN-AMERICA

51


CASE REPORT / Vis. Pan-Am. 2013;12(2):51-53

Figure 2A: Optical Coherence Tomography ( OCT) of the right eye showing massive serous detachment of the macula with retinal elevation extending to the limit of depth of OCT (~3mm).

Figure 1B: Color fundus photograph of the right eye, 4 months following Baerveldt Glaucoma Implant (AMO, Inc, Santa Ana, CA) revision, showing persistently flat macula without serous exudation, with residual CME and no signs of ischemia.

Figure 2B: OCT of the right eye 2 weeks following trabeculectomy revision with insertion of a baerveldt with ligature, and elevation of the IOP to midteens, showing dramatic resolution of the serous detachment with moderate cystoid macular edema and retinal folds. 52

PAN-AMERICA

and intraocular pressures were 6 OD and 19 OS. Fundus examination showed a hyperemic optic nerve head, massive serous detachment of the macula, and dilated tortuous vessels, OD. (Figure 1A) The macular OCT (optical coherence tomography, Zeiss Stratus) scan showed the massive serous detachment (Figure 2A). The patient underwent revision of the trabeculectomy with scleral flap closure, with placement of a Baerveldt glaucoma implant (AMO, Santa Ana CA), with a vicryl ligature to delay function. Postoperatively, the intraocular pressure rose to the high teens with improvement of VA to 20/400 and objective improvement in the macular edema. (Figure 1B) The intraocular pressure gradually decreased, and with the onset of Baerveldt function, four weeks later, the patient developed sudden recurrent hypotony. The visual acuity decreased to hand motions. The anterior chamber was shallow and there was a recurrent massive macular detachment, which extended beyond the inferior arcade. The patient underwent prompt Baerveldt revision to remove the tube from the anterior chamber and place it under the plate (conversion to stage 1) and close the tube entry site. Subsequently, the intraocular pressure rose to the mid-teen levels. The macular detachment resolved and visual acuity improved to 20/400. During follow up over the next 4 months the patientâ&#x20AC;&#x2122;s visual acuity and macular appearance continued to improve, with stabilization of the VA at 20/200. The macula OCT scan showed significant improvement in the macular detachment, with some residual cystoid edema remaining. (Figure 2B) In June 2005, the patient developed a hemiretinal vein occlusion in the fellow left eye. Two weeks later, diffuse macular edema caused the visual acuity to decrease to 20/60. A hematologic work-up revealed elevated plasma fibrinogen and homocysteine levels, as well as prothrombin 20210 and factor V Leiden mutations. He was started on enoxaparin sodium (Lovenox, Sanofi Aventis) and coumadin. Over the following four weeks the VA in the left eye declined to 20/200, and in view of the complicated history of steroid response in the fellow eye, the patient was offered intravitreal bevacizumab injection in his left eye. One week following intravitreal bevacizumab injection in his left eye, prompt resolution of macular edema occurred. VA


Fawzi AA et al. Severe serous macular detachment in hypotony.

improved to 20/30 OS. The response was sustained for about 10 weeks until his VA dropped to 20/70 due to recurrent edema. He received a repeat injection with resolution of the edema and return of his vision to 20/30. One month after the initial injection in the left eye, the patient received an injection in his right eye, which was followed by resolution of the retinal edema, but without improvement in VA . Six weeks following the injection in the right eye, there was mild recurrence of retinal edema, but due to lack of improvement of VA in this eye despite the anatomic response to the injection, further injections were deferred.

Discussion:

Serous macular detachment following glaucoma surgery has rarely been reported as a manifestation of hypotony.1,2 Kokame and associates described moderate serous macular detachment in the setting of hypotony following Baerveldt implant in a patient with uveitis that resolved with reversal of the hypotony.1 Serous detachment in the setting of CRVO is a rare occurrence and is mostly associated with severe ischemia and poor visual outcome.3 More recently, 82% of patients with CRVO were found to have serous macular detachments that averaged 567 microns in height on OCT.4 In contrast, our patient developed localized massive serous detachment (>2000 microns in height) in the macular area of the right eye, without any evidence of ischemic changes, and only following trabeculectomy and lowering of the IOP. Moreover, the retinal detachment showed prompt resolution following elevation of the IOP, and reappeared with recurrence of the hypotony. We believe that mild hypotony, in the face of chronic underlying venous stasis secondary to the complex coagulopathy, caused an imbalance in the retinal interstitial fluid pressure that favored massive serous exudation. There is an association between primary open angle glaucoma and ocular hypertension, as well as steroid induced elevation of IOP and retinal vein occlusion.5 With the increased popularity of intravitreal triamcinolone acetonide (IVTA) as a therapeutic modality for macular edema secondary to vascular occlusion,6 serious considerations must be given to the management of glaucoma in these patients. When surgery is performed to lower the IOP in patients with venous stasis, attention should be paid to the occurrence of persistent postoperative hypotony, which even if mild in nature, could precipitate this

unusual complication of massive serous macular detachment. In young patients with CRVO, especially in the setting of underlying coagulopathy, or suspicion thereof, surgical intervention for glaucoma requires a carefully planned, graded or staged approach, which avoids sudden or severe lowering of the intraocular pressure, to prevent the occurrence of massive exudative detachments as in our patient. The use of bevacizumab as an alternative treatment approach for the macular edema in patients with vascular occlusions, who have a history of glaucoma or are known to have steroid response glaucoma,6 may avoid the need for glaucoma surgery in these patients. The occurrence of massive serous macular detachment in the setting of hypotony should alert ophthalmologists to an underlying venous stasis and should prompt a systemic work-up for an underlying coagulopathy. Moreover, in patients with known steroid response glaucoma as in our patient, bevacizumab may offer an effective and safe alternative to IVTA for CME in retinal vascular occlusions. Recognizing the role of hypotony in precipitating massive macular serous detachment in the setting of venous stasis, with immediate treatment directed to elevating the IOP, combined with the use of bevacizumab as an adjuvant, might offer a safe and effective option to prevent permanent vision loss in affected patients.

REFERENCES 1. Kokame GT, de Leon MD, Tanji T. Serous retinal detachment and cystoid macular edema in hypotony maculopathy. Am J Ophthalmol. 2001; 131:384-6. 2. Bhagat N, Lim JI, Minckler DS, Green RL. Posterior uveal effusion syndrome after trabeculectomy in an eye with ocular venous congestion. Br J Ophthalmol. 2004; 88:153-4 3. Weinberg D, Jampol LM, Schatz H, Brady KD. Exudative retinal detachment following central and hemicentral retinal vein occlusions. Arch Ophthalmol. 1990 ; 108: 271-5 4. Ozdemir H, Karacorlu M, Karacorlu S. Serous macular detachment in central retinal vein occlusion. Retina. 2005;25:561-3. 5. Hayreh SS, Zimmerman MB, Beri M, Podhajsky P. Intraocular pressure abnormalities associated with central and hemicentral retinal vein occlusion. Ophthalmology. 2004 ;111:133-41. 6. Kaushik S, Gupta V, Gupta A, Dogra MR, Singh R. Intractable glaucoma following intravitreal triamcinolone in central retinal vein occlusion. Am J Ophthalmol. 2004;137: 758-60 7. Rosenfeld PJ, Fung AE, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for macular edema from central retinal vein occlusion. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):336-9. Arch Soc Esp Oftalmol. 2000, 75:117-20.

PAN-AMERICA

53


CASE REPORT / Vis. Pan-Am. 2013;12(2):54-56

Novel Surgical Technique in Refractory Open Angle Glaucoma: Case Report Rodolfo A. Perez Grossmann, MD1, Daniel E. Grigera, MD2, Alan Wenger, MD1. 1- Instituto de Glaucoma y Catarata, Lima, Perú. 2- Glaucoma Service, Hospital Oftalmológico Santa Lucía, Buenos Aires, Argentina. Funding: None Financial/Proprietary interest: None

Corresponding author: Rodolfo A. Perez Grossmann Instituto de Glaucoma y Catarata Av. Reducto 1330 Miraflores - Lima , Peru Phone: 2415971 4463957 2413113 Email: raperezg@hotmail.com Date of submission: 12/3/2013 y Date of Approval: 09/04/2013

Abstract

Figure 1: Visual field of the patient at admission time. Notice the advance damage.

Purpose: To review two cases of open angle glaucoma(OAG) refractory to medical and surgical treatment that underwent a novel surgical technique. Methods: Case reports of a novel surgical technique which consists in a trabeculectomy with Mitomycin C and aqueous diversion to the suprachoroidal space. Results: The target intraocular pressure remains stable after surgery without using any medical treatment. No severe complications were observed during follow-up. Conclusion: Managing intraocular pressure in refractory glaucoma has always been a challenge, and the need of both surgical and medical approaches is common. This novel surgical technique has the advantage of using 2 filtering pathways, which allows an adequate aqueous humor drainage even if one of the pathways fails.

Introduction:

Primary open angle glaucoma (POAG) is a progressive, chronic disease where intraocular pressure (IOP) and other factors produce an optic neuropathy with loss of retinal ganglion cells and their axons, becoming a major cause of blindness worldwide1,2. Trabeculectomy has been the most used surgical approach since it was described by Cairns3, providing lower IOP and lesser daily fluctuation when compared to medical treatment4,5. Despite this, at least 20% of eyes that have undergone trabeculectomy will need topical glaucoma medication to achieve the

54

PAN-AMERICA

target IOP five years after surgery6. Antimetabolites are used frequently to improve the success rate of trabeculectomy; however, both 5-fluorouracil and Mitomycin C have been associated with significant sideeffects and complications7. We present two case reports of OAG refractory to both surgical and medical treatment that underwent a novel surgical technique.

Case Reports: Case 1:

An 80-year old male patient with advanced POAG was referred with a best corrected visual acuity (BCVA) of 20/30 in both eyes (OU) and IOP of 21 mmHg in the right eye (OD) and 19 in the left eye (OS) with maximal medical therapy. Slit-lamp examination showed mild cataract and an optic nerve cupping of 0.9 OU. Gonioscopy was Grade IV in the Shaffer classification OU. The visual field showed advance damage (Figure 1). Combined surgery with Mitomycin (3 minutes) was performed in the right eye, maintaining an IOP close to 14 mmHg for a few months, but resulting in fibrosis of the bleb and a need to return to maximal medical therapy. Considering this, we proceeded to perform a new trabeculectomy with Mitomycin C (5 minutes) in the right eye which resulted again in filtration failure. Despite adding a fixedcombination of timolol / dorzolamide and latanoprost, bleb fibrosis made the IOP raise again to 23 mmHg OD. We decided to perform a novel glaucoma surgery: Trabeculectomy


Grossmann RAP et al. Novel surgical techniques in refractory glaucoma.

with Mitomycin C and suprachoroidal derivation. At the first postoperative day IOP was 8mmHg. In the course of the one year follow-up, we obtained a stable BCVA of 20/25, an IOP between 8 and 10 mmHg and the visual field remained stable (Figure 2).

Case 2:

A 32-year old male patient with pigmentary glaucoma was referred with a BCVA of 20/60 OU and an IOP under medical treatment of latanoprost, timolol and brimonidine of 16mmHg OD and of 23mmHg OS. He underwent an iridotomy OU 12 years ago and argon laser trabeculoplasty (ALT) OU 12 years ago. In gonioscopy examination we observed increased pigment in the trabecular meshwork. The optic nerve cupping was 0.8 OU. Due to visual field damage progression (Figure 3) we decided to perform a trabeculectomy with Mitomycin C and suprachoroidal derivation in the left eye. At the first postoperative day IOP was 6mmHg and in the course of one year follow-up we obtained a stable BCVA of 20/40, and an IOP between 6 and 11 mmHg with no medical glaucoma medication. Also, the visual field remained stable (Figure 4).

Figure 2: Visual field after trabeculectomy with mitomycin C and suprachoroidal derivation. There is no significant advance in visual field damage.

Surgical Procedure:

Patients were operated under topical (Proparacaine hydrocholidre 0.5%) and subconjunctival (Lidocaine 2%) anesthesia. The procedures were performed in the superior temporal quadrant because of conjunctival scarring from previous surgeries. A 6 mm fornix-based conjunctival incision with 2 mm relaxing incisions in each end was performed to provide better visualization of the operating area. Next step was a Tenon´s capsule dissection and episcleral vessel cauterization. Using a 2 mm Crescent knife we then performed a 5 x 5 x 5 mm limbusbased scleral flap of 50% scleral thickness that reached clear cornea. Later, a second rectangular 4 x 3 x 4 mm limbus-based scleral flap of 30% scleral thickness was made below the previous one. Mitomycin-C (0.4 mg/mL) was applied for 3 minutes with a microsponge in a central area of 7 mm2 and then irrigated with saline solution. Later, the inner flap was divided in three 1-mm flaps performing 2 cuts along the anterior-posterior axis with Vannas scissors and then the 1-mm central flap was removed. Using a 2-mm Crescent knife we performed a 3-mm incision of the 20% remaining scleral thickness, located 3-mm posterior to the limbus, reaching the suprachoroidal space. Using a blunt spatula we

Figure 3: Visual field of the patient at admission time.

Figure 4: Visual field after trabeculectomy with Mitomycin C and suprachoroidal derivation. There is no significant advance in visual field damage. PAN-AMERICA

55


CASE REPORT / Vis. Pan-Am. 2013;12(2):54-56

Figure 5: The 2 lateral flaps are inserted in the suprachoroidal space, forming a channel that will direct the aqueous humor from the anterior chamber to the suprachoroidal space.

carefully dissected the suprachoroidal space and then performed a bite in the posterior lip of this scleral incision with a 0.9 mm Kelly Punch. The 2 lateral flaps were inserted in the suprachoroidal space, forming a channel that will direct the aqueous humor from the anterior chamber to the suprachoroidal space (Figure 5). A 1-mm penetrating incision was made at the limbus (base of the second scleral flap) with a sideport knife, followed by a bite with a 0.9 mm Kelly Punch and basal iridectomy with Vannas scissors to communicate the anterior chamber with the scleral channel. The channel was covered with the first scleral flap in order to create a tunnel and sutured with 1 stitch in each corner and 2 stitches in each of the 3 sides of the flap using Nylon 10/0 in order to get a watertight seal. Finally, the conjunctiva was sutured to the limbus using Nylon 10/0.

Discussion:

The wound healing process is still the most important factor for success or failure in glaucoma filtration surgery, affecting IOP control and, therefore, progression of disc cupping and of visual field loss8. Eyes in which trabeculectomy has failed have a higher risk of further failure with subsequent filtering surgeries9 and glaucoma draining devices10 Emi et al11 studied hydrostatic pressure in the suprachoroidal space by direct cannulation and found a significant fall from the anterior chamber to the suprachoroidal space. This difference, at an IOP of 15 56

PAN-AMERICA

Figure 6: An evident suprachoroidal space is shown by UBM. A subconjunctival space is also present and, thus, the sclera appears surrounded by both.

mmHg was -0.8 ±0.2 mmHg in the anterior suprachoroidal space, increasing to -3.7 ± 0.4 mmHg in the posterior suprachoroidal space. This negative difference in hydrostatic pressure and the clinically relevant resorptive function of the choroid are the main reasons to the suprachoroidal surgical approach11,12. Also, the natural counterpressure of the suprachoroidal space plays a role in preventing severe postoperative hypotony and the negative pressure gradient helps maintaining aqueous drainage8. This procedure does not depend on the filtrating bleb, so it can be performed in eyes where the conjunctival scarring would not allow a conventional filtration surgery13. Unlike classic trabeculectomy, our surgical procedure has the advantage of using 2 different drainage pathways to lower the IOP, the anterior chamber to subconjunctival space fistula and the uveoescleral drainage through the suprachoroidal space. If the filtration bleb becomes increasingly vascularized, and/ or excessive capsular fibrosis appears, the uveoescleral pathway is still patent. In our patients, both subconjunctival and suprachoroidal fluid have been found by means of Ultrasound biomicroscopy . The typical image is an unusually evident suprachoroidal space (Figure 6). No severe complications were found in both cases, achieving the target IOP without appealing to any glaucoma medication.

REFERENCES 1- Primary-open glaucoma and myopia: a narrative review.Loyo-Berríos NI, Blustein JN. WMJ. 2007 Apr;106(2):85-9, 95. Review. 2- Number of people with glaucoma worldwide. Quigley HA. Br J Ophthalmol. 1996 May;80(5):38993. Review. 3- Cairns JE. Trabeculectomy. Preliminary report of a new method. Am J Ophthalmol. 1968 Oct;66(4):673-9. 4- Willensky JT, Zeimer RC, Gieser DK, Kaplan BH. The effects of glaucoma filtering surgery on the variability of diurnal intraocular pressure. Trans Am Ophthalmol Soc. 1994;92:377-81; discussion 381-3. 5- Lichter PR, Musch DC, Gillespie BW, et al. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. 6- Molteno AC, Bosma NJ, Kittelson JM. Otago glaucoma surgery outcome study: long-term results of trabeculectomy--1976 to 1995. Ophthalmology. 1999 Sep;106(9):1742-50. 7- Trabeculectomy With Mitomycin C in Pseudophakic Patients With Open-angle Glaucoma: Outcomes and Risk Factors For Failure.Am J Ophthalmol 2006;141:652–659. 8- Jordan JF, Engels BF, Dinslage S, et al. A novel approach to suprachoroidal drainage for the surgical treatment of intractable glaucoma. J Glaucoma. 2006 Jun;15(3):200-5. 9- Broadway DC, Chang LP. Trabeculectomy, risk factors for failure and the preoperative state of the conjunctiva. J Glaucoma. 2001 Jun;10(3):237-49. 10- Unal M, Kocak Altintas AG, Koklu G, Tuna T. Early results of suprachoroidal drainage tube implantation for the surgical treatment of glaucoma. J Glaucoma. 2011 Jun-Jul;20(5):307-14. 11- Emi K, Pederson JE, Toris CB. Hydrostatic pressure of the suprachoroidal space. Invest Ophthalmol Vis Sci. 1989 Feb;30(2):233-8. 12- Francis BA, Singh K, Lin SC, et al. Novel glaucoma procedures: a report by the American Academy of Ophthalmology. Ophthalmology. 2011 Jul;118(7):1466-80. 13- Yablonski ME. Trabeculectomy with internal tube shunt: a novel glaucoma surgery. J Glaucoma. 2005 Apr;14(2):91-7.


Message from the Chairman of the Board, PAOF

Message from the Chairman of the Board, PAOF William De La Peña, MD Chair of the Board of Directors, Pan-American Ophthalmological Foundation

The Pan-American Ophthalmological Foundation is proud to support the educational and academic activities of the Pan-American Association of Ophthalmology. Support of our emerging young clinicians and scientists from the Americas such as those who presented at the recent Pan-American Research Day of the PAAO is key to the central mission of the PanAmerican Association. As always, we thank Allergan, Inc. and our other partners for their support of PanAmerican Research Day. Thanks to this generous support, the Pan-American offered several awards at this meeting: • Arno Habicht Awards for Research Sciences ... João Paulo Fernandes Felix MD (Brazil) ... Renán Albert Mendonça Rodrigues MD (Brazil) ... João Marcello Fortes Furtado MD (Brazil) • David & Juliana Pyott Foundation Travel Award ... Julio C. Hernández Camarena MD (Mexico) • Allergan Latin America Research Incentive Awards in Glaucoma ... 1st place – Rafael Lacerdo Furlanetto MD (Brazil) ... 2nd place – Jeramías Gastón Galletti MD (Argentina) • Allergan Latin America Research Incentive Awards in Cornea ... Samantha Herretes MD (Venezuela) • Allergan Latin America Research Incentive Awards in Retina ... Raúl Velez Montoya MD (Mexico)

• Tyson Research Initiative/PAOF/Retina Research Foundation Travel Grants ... Mariana Ingolotti (Argentina) ... Lynsie M. Morris (USA) ... Fatma Zaguia (Canada) What makes the Pan-American Association so unique is the scientific and cultural exchange between ophthalmologists from all over the world; this exchange ultimately enhances ophthalmic care in the Americas. I would like to thank each and every one of you who are Pan-American members and especially those who are Circle of Vision members. Please consider participating in our upcoming Carnival dinner on August 9, 2013, in Rio de Janeiro. The proceeds from this event support our educational programs. For more information please contact our Executive Director, Teresa Bradshaw, at teresa.bradshaw@paao.org. Your support helps our programs to grow and continue to fulfill the needs of our ophthalmologists.

William De La Peña, MD Chairman of the Board Pan-American Ophthalmological Foundation

PAN-AMERICA : 57


PAAO / Vis. Pan-Am. 2013;12(2):58-59

First retinal implant surgery in the Middle East Riyadh, Saudi Arabia, February 4, 2013

Fig. 1. Dr. Arevalo (left) and Dr. Rizzo (right) during the procedure.

Fig. 2. The silicone band part of the implant is placed under the rectus muscles. The flexible cable and electrode array will be placed in the vitreous cavity after vitrectomy through a sclerotomy and fixed with a retinal tack.

58

PAN-AMERICA

A retinal prosthesis known to many as “the bionic retina” was implanted for the first time in the Middle East in a patient at the King Khaled Eye Specialist Hospital (KKESH), Riyadh, Saudi Arabia, on February 2. Called the Argus II Retinal Prosthesis System, it was surgically implanted by Dr. Fernando Arevalo, Adjunct Professor of Ophthalmology at Wilmer Eye Institute (Retina Division) at Johns Hopkins University School of Medicine, and Chief of the Vitreo-retinal Division at KKESH, who reports that the patient, who has an advanced form of retinitis pigmentosa (RP), is doing well, with no inflammation, and the implant looks in excellent location in the retina. A second Argus II Retinal Prosthesis surgery was performed on February 3 by Dr. Arevalo’s team on another patient with RP. The Argus II received European marketing approval (CE Mark) as the result of a three-year international clinical trial, which demonstrated the device’s long-term safety, performance and reliability. It is the first artificial retina to receive marketing approval anywhere, and its developer, Second Sight Medical Products, has obtained FDA recommendation for approval in the United States.* There are an estimated 1.2 million people worldwide with RP, including 100,000 in the United States. Numerous strategies to treat RP have been investigated, including intravitreal injection of growth factors, genetic therapy, vitamin A supplementation, surgical transplantation of the neural retina and retinal pigment epithelium, ozone therapy, and electrical stimulation. Unfortunately, none of these have been effective. The Argus II is 3 x 5 mm in size, which corresponds to a letter size page at hands distance. This is what is needed to provide mobility. It consists of a 60-electrode grid, about 200 micrometers in diameter – i.e.


First retinal implant in the Middle East.

Fig. 3. Surgical team from left to right, Brian Coley (Second Sight), Francesco Merlini (Second Sight), Stanislao Rizzo, MD (Pisa, Italy), Saba Al-Rashaed, MD, J. Fernando Arevalo, MD FACS, Khalid Al Robaie, MD (fellow), Tariq Al-Hamad, OD.

a little over the width of a hair, surgically implanted on the retina, where the electrodes transmit information taken from an external video camera mounted on a pair of eyeglasses worn by the user. A series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. Patients then learn to interpret these visual patterns thereby regaining some visual function. The device has enabled clinical trial participants who are profoundly blind, due to damaged photoreceptors, to see shapes, locate objects and recognize large letters. Users of the device perceive patterns of light, which they learn to interpret as vision. Over the next couple of weeks, according to Dr. Arevalo, the implanted Argus II will be tested and customized for the patients. If the process, which includes training and

rehabilitation, goes as planned, the patients may be using the device at home by the end of this month. The Argus II is a secondgeneration version of the device, which, originally, had a 16-electrode grid. “We have known of several patients who have been implanted with the Argus II and can perceive color, future generations of Argus II maybe upgraded to one day restore color vision for these blind patients” said Dr. Arevalo. Dr. Arevalo added “As I was implanting the first device in this area of the world I could only think about all the hard work that my team had made to get us here, and how many patients we will benefit with this implant in Saudi Arabia and worldwide”. * The U.S. Food and Drug Administration on February 14, 2013 approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). PAN-AMERICA : 59


PAAO / Vis. Pan-Am. 2013;12(2):60

Vision Pan-America Editor’s Choice Award 2013 Created to recognize the best original scientific paper published in our journal during 2012, this award was selected by a jury, constituted of the members of the Editorial Board, nominated by the Editor-in-Chief, Paulo E. C. Dantas, MD.

We are pleased to announce the winners for the 2012 edition: 1st place (US$1,000.00): Provocative tests, functional exams and daily curve of intraocular pressure in glaucoma suspects. Authors: Sebastião Cronemberger, Nassim Calixto, Hélio de Maria Vieira Filho, Tiago Tomaz de Souza, Camila Araújo Souza and Roberto de Alencar Gomes. From Glaucoma Service, Federal University of Minas Gerais, Brazil 2nd place (Certificate of recognition): Topical Steroids in Bacterial Keratitis: A Retrospective Study. Authors: Alejandro Lichtinger, Faik Orukov, Avi Solomon, Claudia Yahalom and Joseph Frucht-Pery. From Department of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. 3rd place (Certificate of recognition): Quality of life in keratoconus patients submitted to corneal collagen crosslinking. Authors: Kelly Stefani Klein, Rita Caregnato, Eduardo Périco, Nelson Julio Balestro Junior. From post-graduation program of Centro Universitário UNIVATES, Lageado, Rio Grande do Sul, Brazil The awards will be presented at the upcoming XXXVII Brazilian Congress of Ophthalmology/ XXX Pan-American Congress of Ophthalmology in Rio de Janeiro, Brazil during the opening ceremony.

Paulo E.C. Dantas Editor-in-Chief, Vision Pan-America, The Pan-American Journal of Ophthalmology

60

PAN-AMERICA


Events 2013

XXX Pan-American Congress of Ophthalmology XXXVII Brazilian Congress of Ophthalmology August 7-10, 2013 / Rio de Janeiro, Brazil PAN-AMERICAN ASSOCIATION OF OPHTHALMOLOGY AND BRAZILIAN COUNCIL OF OPHTHALMOLOGY GUESTS OF HONOR 2013

• Dr. Alice McPherson (USA)

• Mr. David Pyott (Scotland)

PAN-AMERICAN ASSOCIATION OF OPHTHALMOLOGY PRIZES AND AWARDS

• A. Edward Maumenee Award for Distinguished Services – Mr. Nelson R. Marques (Brazil)

• Benjamin F. Boyd Humanitarian Award – Dr. Juan Verdaguer (Chile)

• Gradle Medal for Good Teaching – Dr. Newton Kara José (Brazil)

• Vision Pan-America Editor’s Choice Award – Dr. Sebastião Cronemberger (Brazil)

• Paul Kayser/RRF Global Award (presentation and lecture) 07 Aug 2013, 12h00 – 12h30, Sala 103 • Troutman-Véronneau Prize (presentation and lecture) - 07 Aug 2013, 11h30 – 12h00, Sala 103

PAN-AMERICA : 61


PAAO / Vis. Pan-Am. 2013;12(2):61-63

AWARDS FROM SUPRANATIONAL ORGANIZATIONS • Lions/PAAO Award for the Prevention of Blindness

• ICO Golden Apple Award

• IAPB 20/20 Award – to be announced

PAN-AMERICAN ASSOCIATION OF OPHTHALMOLOGY NAMED LECTURES

• Gradle Lecture: Dr. Eduardo Mayorga (Argentina)

• Moacyr E. Alvaro Pan-American Lecture: Dr. Cristián Luco (Chile)

BRAZILIAN COUNCIL OF OPHTHALMOLOGY MAGNA LECTURE

• AJO Lecture: Dr. Juan Batlle (Dominican Republic)

• Gradle Lecture: Dr. Eduardo Mayorga (Argentina) “Permanecer actualizado en el siglo XXI: Estrategias y Tecnología / Keeping current in the XXI century: Strategies and Technology” 07 Aug 2013, 12h30 – 13h00, Sala 103 • Moacyr E. Alvaro Pan-American Lecture: Dr. Cristian Luco (Chile) “Moacyr E. Alvaro: Un lider panamericano” 07 Aug 2013, 09h00 – 09h30, Sala 204 A/B • AJO Lecture: Dr. Juan Batlle (Dominican Republic) “Cataract Surgery in Latin America; Current Situation” 07 Aug 2013, 11h00 – 11h30, Sala 103

• Dr. Paulo Augusto de Arruda Mello (Brazil)

62

PAN-AMERICA

• Dr. Paulo Augusto de Arruda Mello (Brazil) “Glaucoma além da pressão” 07 Aug 2013, 09h30 – 10h30, Sala 204 A/B


Events 2013

Programação Social/ Social Program/Programación Social 07 Aug 2013 - 18h30/6:30 PM Cerimônia de Abertura seguida de cocktail/ Opening Ceremony followed by cocktail/ Cerimonia de aperture seguida de cocktail - Riocentro

08 Aug 2013 Jantar da Fundação Pan Americana Churrascaria Porcão/Carnival Dinner of the Pan-American Foundation/Ceña de Carnaval de la Fundación Pan-Americana

09 Aug 2013 - 18h30/6:30 PM Festa de Confraternização/Confraternization Party/Fiesta de Confraternización - Riocentro Show do Monobloco e Bateria da Escola de Samba da Modicade Independente de Padre Miguel

More details at www.cbo2013.com.br

>>

PAN-AMERICA : 63


RAYNER Toric IOL experts, the world over.

M-flex® T

Sulcoflex® Multifocal Toric

Sulcoflex® Toric

T-flex®

The most complete toric IOL family • Toric, multifocal toric and pseudophakic supplementary IOL ranges

• Haptic designs that ensure uncompromising centration and stability • Manufactured from Rayacryl®, with superb handling characteristics and high biocompatibility • Accurate, predictable and sustainable refractive outcomes • Extensive power ranges, including customised cylinders up to 11.0D* • Online calculation and ordering available at www.raytrace.net * Full power range information and more available on www.rayner.com

rayner.com

Note: These products are not available for sale in the US. 02/13 Copyright Rayner Intraocular Lenses Limited.


{

TORIC Aspheric IOL

T

toric

}


4 :

PAN-AMERICA

Paao vol 12 no. 2  

Paao vol 12 no. 2