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ISSUE
12 | 10 | 21
HIGHLIGHTS genetics of hyperopia 04 The and its advanced
ESCRS
treatment modalities What Works! — 06 Find Strategies for successful cataract surgery in refractive patients
ESCRS
OCT takes a step 10 Home forward with results from first U.S. longitudinal study Topic in AMD: 13 Hot Biosimilars — To use or not to use?
ASRS
ASRS
Published by
ASRS 2021 Update
Matt Young
CEO & Publisher
Hannah Nguyen COO & CFO
Robert Anderson Media Director
Gloria D. Gamat Chief Editor
Brooke Herron
What’s new in the specialized world
Editor
Maripet Ledesma Poso Editor
of ocular oncology?
Ruchi Mahajan Ranga Brandon Winkeler International Business Development Writers
Andrew Sweeney Elisa DeMartino Hazlin Hassan Olawale Salami Nick Eustice Sam McCommon Tan Sher Lynn Maricel Salvador Graphic Designer
A
lthough ocular tumors are relatively rare compared to conditions like cataract or diabetic retinopathy, these uncommon cancers deserve their share of the spotlight, too. Thus, at the 39th American Society of Retina Specialists (ASRS 2021) Scientific Meeting, experts shared some of the latest developments in this specialized field during the Ocular Oncology Symposium.
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A novel, investigational drug First up was Dr. Prithvi Mruthyunjaya who shared results from “A Phase 2 Safety and Efficacy
by Brooke Herron
Trial of AU-011, a Virus-Like Drug Conjugate, with Dose Escalation and Randomized Masked Expansion in Uveal Melanoma”. “AU-011 is a potential first in cancer molecule used to treat tumors and preserve vision,” began Dr. Mruthyunjaya. “These viral-like drug conjugates or VDCs are essentially inactivated human papillomaviruses.” VDCs are activated with an ophthalmic laser generating singlet oxygen that disrupts the tumor Cont. on Page 3 >>
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12 October 2021 | Issue #4
CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
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cell membrane, leading to acute necrosis and anti-tumor immunity, he continued. Administered via the suprachoroidal space (SC), AU-011 is designed to treat primary indeterminate lesions (IL) and small choroidal melanoma (CM). The phase 2 trial evaluated the safety and efficacy of AU-011, while a doseescalation phase is ongoing to establish the maximum safe and well-tolerated dose and treatment regimen. Dr. Mruthyunjaya explained that the phase 2 suprachoroidal study is an openlabel dose escalation phase where the earlier cohorts had increased doses of the medication and then subsequently increased laser application. “Currently, 14 subjects have been enrolled to date. The study is now in the final cohort, which is cohort 6, using the dose of 80µg given over two injections in separate quadrants with suprachoroidal delivery. And after the laser, the application is applied twice. This is repeated every three weeks as one cycle, and up to three cycles are permitted,” explained Dr. Mruthyunjaya, adding that patients enrolled have typically small uveal melanomas, but these are tumors with documented growth. “The preliminary safety data appears to be favorable,” he shared. No serious adverse events, dose-limiting toxicities, or severe (grade 3) adverse events have been reported. Although there have
been reports of mild anterior chamber inflammation and one report of moderate anterior scleritis. Moving forward, he said that SC administration may improve the therapeutic index and optimize treatment parameters compared to intravitreal administration. Further, the favorable safety profile supports the continued dose escalation, and a randomized controlled expansion phase is planned to demonstrate the safety and efficacy of AU-011.
COVID-19’s effect on uveal melanoma Next up was Dr. Amy C. Schefler, who shared her insights on the “Comparison of Tumor Size at Presentation and Genomics in Uveal Melanoma Patients Before and After the COVID-19 Pandemic”. We all remember how COVID-19 caused elective surgeries and office visits to be postponed and canceled — which is still occurring today in areas with high infection and hospitalization rates. According to Dr. Schefler, one of the devastating effects of this has been later presentation of patients with many cancer types, including ocular cancers, as she experienced personally in one patient’s case. This led her to conduct a study that compared 40 patients diagnosed with uveal melanoma and were treated from August to December 2019 (before the
pandemic), with 40 patients who were treated from April to September 2020 (during the pandemic). Among the key measurements, median tumor thickness and median largest base diameter were recorded. In 2019, this was 4.3mm (range 1.2-13.5) and 12.8mm (range 8-24mm), respectively; in 2020, this was similar at 4.5mm (range 1.4-10.6mm) and 13.3mm (range 8-20.5mm), respectively. Although this study did not identify any significant differences in uveal melanoma stage, size, and genomics at presentation in patients before and after the COVID-19 pandemic began, Dr. Schefler recommended that “further long-term studies are needed to assess the ultimate impact of the pandemic on patient presentation with uveal melanoma”.
Long-term impacts of MIVS/Phaco The final presenter in this distinguished panel was Dr. Timothy G. Murray, who shared details from “Combined MIVS/ Phacoemulsification for Concomitant Management of Retinal Pathology With Cataract: 5-Year Follow-up of a Large, Consecutive Case Series”. This review looked at 648 eyes of 611 patients undergoing combined microincision vitrectomy surgery (MIVS) (23/25 gauge) with phacoemulsification/ IOL implantation. Of these, 330 eyes (51%) had intraocular tumors. Eyes were evaluated by indication for surgery, visual and anatomic outcomes, and short and long-term complications over a mean follow-up of 61.2 months. Dr. Murray shared that 86% of eyes had a three-line visual acuity (VA) gain and all received a posterior chamber intraocular lens (PC-IOL) without compromise. Intraoperatively, 3.9% had capsular tears; while postoperatively, 3.2% had vitreous hemorrhage, 1.7% had epiretinal membrane formation, and 1.8% had retinal detachment (1.8%).
Although ocular cancer is rare, it usually develops without any warning signs.
“For these patients, over the five-year window, vision was stable at 20/46,” shared Dr. Murray. These results led him to conclude that combined anterior and posterior surgery is an effective approach in a long-term follow-up of an extended patient population. “I think it offers unique opportunities for our patients,” he concluded.
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12 October 2021 | Issue #4
Eye Strains
The genetics of hyperopia and its advanced treatment modalities by Tan Sher Lynn
E
ven though not as common as myopia, hyperopia can cause debilitating symptoms that affect daily life, such as blurred vision, headaches and eye strains, binocular dysfunction, amblyopia, and strabismus. Consequently, at the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021), leading ophthalmologists shared their knowledge about treating this condition.
Common refractive error genes associated with hyperopia According to Dr. Caroline Klaver from the Netherlands, hyperopia, which is the plus end of the refractive error spectrum, is becoming rarer with each generation. Common refractive error
genes are associated with hyperopia, with the ‘non-myopia’ variant predisposing to hyperopia. “We found that all retinal cell types express refractive error genes. A common refractive error gene is the GJD2. Six genes are currently known for nanophthalmos/microphthalmos – MFRP, PRSS56, MYRF, TMEM98, CRB1, and Best1,” Dr. Klaver shared. “The MFRP gene is a gene selectively expressed in retinal pigment epithelium (RPE). Biallelic mutations can cause retinal degeneration. MFRP interacts with PRSS56. Interestingly, when both of these genes are knocked out, ADAMTS19 is upregulated as a compensation mechanism, causing eye elongation,” she continued. “Meanwhile, the MYRF gene is a
transcription factor essential for myelin sheaths. It is known to interact with TMEM98 in the retinal pigment epithelium (RPE). If these two genes bind, then MYRF becomes nonfunctional. On the other hand, TMEM98 is associated with ocular defects such as nanophthalmos, high hyperopia, high myopia as well as cone-rod dystrophy,” Dr. Klaver further explained. “Revealing the function and expression sites of these genes improves our understanding of the crosstalk across the retina-RPE-choroid-sclera to regulate eye growth,” she summed up.
Advances in amblyopia treatment Meanwhile, Dr. Ken Nischal from the U.S., remarked that amblyopia is a brain issue, not an eye issue as previously thought. According to him, asymmetry in the quality of visual input across the two eyes leads to reduced visual acuity in the affected eye with no obvious pathology in the eye, thalamus, or cortex. “Severity of amblyopia depends on the age at initiation and type of asymmetry — whether it is unequal alignment
CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
(strabismus), unequal refractive error (anisometropia), or form deprivation (eg. cataract). The critical period for developing amblyopia in children extends to eight years, and it becomes increasingly resistant to reversal with age,” Dr. Nischal shared. Traditional therapy includes patching (occlusion therapy) or atropine and optical penalization. “Even after several years of treatment, many amblyopes fail to reach successful outcomes. Even successfully treated amblyopic children experience a recurrence in approximately 25% cases,” he noted. The key to treating amblyopia lies in augmenting cortical plasticity. Internal augmentation includes perceptual visual learning, and newer modalities like video games, liquid crystal glasses, and flicker lenses; while external augmentation involves the use of drugs and transcranial magnetic stimulation. “Perceptual visual learning is thought to undo the development damage incurred during the brain’s ‘plastic’ period in early life,” added Dr. Nischal. “Liquid crystal glasses is a new method where the liquid crystal lens in front of the non-amblyopic eye is used as an intermittent flickering shutter that switches between ‘on’ or occlusion, and ‘off’ or light transmission. Children seem to prefer using these glasses,” he said. Flicker glasses use rapid alternating occlusion at flicker frequencies to gently stimulate the visual system and encourage both eyes to naturally work together, restoring binocular vision and depth perception.
“Last but not least, video gaming is based on the principle that it strengthens a broad range of visual tasks in adults with normal vision, including light and contrast sensitivity, visual crowding, and visual attention,” he further explained. “Three approaches of video gaming have been developed to treat amblyopia — playing a video game with the non-amblyopic eye-patched, using dichoptic viewing as an anti-suppression strategy, and playing a video game designed to develop stereopsis.” Dr. Nischal also mentioned gene expression manipulation as an exciting treatment modality. “Pharmacologic manipulation of gene expression through the inhibition of histone deacetylase activity has an effect on brain plasticity. Animal models have been shown to support the use of histone deacetylase inhibitors to treat amblyopia,” he said.
Excimer laser corneal surgery in hyperopic eyes According to Dr. Jesper Hjortdal from Denmark, corneal refractive surgery started with correction of myopia, but the first publication on correction of hyperopia already appeared in 1992. Dr. Hjortdal noted that excimer laserbased correction of hyperopia is more difficult than correction of myopia due to central steepening, peripheral flattening, a smaller optical zone, and less correction that can be obtained. “In corneal excimer laser correction, you need to remove more tissue at the periphery in contrast to laser correction in myopia where we remove most tissue
at the center. Centering the laser is especially important in correction for hyperopia due to the smaller optical zone,” he said. “Accommodation in younger subjects may result in differences in manifestation and cycloplegic refraction resulting in apparent under-correction. Nevertheless, there has been significant improvement in terms of safety, efficacy, stability, and accuracy of laser-assisted in situ keratomileusis (LASIK) treatment for hyperopia and hyperopic astigmatism within the past two decades as shown by meta-analysis,” he added. “I recommend correction of up to only +4 diopters of spherical equivalent refraction. Femtosecond LASIK is possibly preferable to surface ablation techniques,” Dr. Hjortdal concluded.
SMILE and ReLimp in correcting hyperopic errors Dr. Osama Ibrahim from Alexandria, Egypt, said that small incision lenticule extraction (SMILE) causes less dry eyes than the excimer laser. However, there are still challenges in performing SMILE in hyperopic eyes because the lenticule is very thin at the center and thick at the peripheral, which makes the dissection of the lenticule more difficult. Also, in hyperopic astigmatism, the shape of the lenticule is very peculiar — thick in one meridian and thin in the other. “SMILE is a safe and effective option for hyperopia and hyperopic astigmatism, although it has lesser stability and predictability than in myopic eyes,” explained Dr. Ibrahim. “The higher the errors, the more the regression. The trick is to increase the transition zone, which reduces the regression.” He also noted that refractive lenticule implantation (ReLimp) is a safe, stable, and effective option to treat very high hyperopia, such as unilateral aphakia. Nevertheless, ReLimp for the treatment of high hyperopia involves some challenges.
Hyperopia can cause debilitating symptoms that affect daily life, including eye strains.
“We need to steepen the anterior corneal surface to avoid resistance of intact Bowman and posterior bulging. Proper centration and maintaining corneal physiology are important. The use of ReLimp in correcting lower hyperopic errors needs more refined technique and longer follow up,” he commented.
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12 October 2021 | Issue #4
Find What Works! Experts share strategies for successful cataract surgery in refractive patients by Olawale Salami
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hen it comes to cataract surgery procedures in patients with previous refractive surgery, getting the best results requires consideration of several factors, namely variations in corneal power within the central zone, changes in the anterior to the posterior corneal ratio which invalidate the assumed keratometric index of refraction, and disrupted corneal radius and effective lens position (ELP) relationship. This was the premise of Dr. Fam Han Bor’s presentation yesterday during the CSRS Symposium at the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021). Dr. Fam is a senior consultant at NHG Eye Institute and Tan Tock Seng Hospital in Singapore.
TK values matter The data presented by Dr. Fam emphasized the importance of keratometry (K) values in intraocular lens (IOL) power predictions. “In our previous work, we have shown that the Barrett’s
True K method with ‘history’ was the best performing method of IOL power calculation,” shared Dr. Fam. “Using the IOL Master-700, we measured the anterior and posterior corneal curvatures and the corneal thickness, and with these three parameters, generated the total corneal power. This is modified slightly to generate the total keratometry (TK) values, and the aim is to have these values similar to the standard K value. In doing these, we excluded the need for a different IOL constant for each IOL power formula available today.”
“In patients with previous refractive surgery, IOL power calculation is the crux of the matter when it comes to cataract surgery.” — Dr. Fam Han Bor, Tan Tock Seng Hospital, Singapore
Dr. Fam added: “For the traditional formula, we used a reverse double K calculation. Here, we found that Barrett’s True K and Barrett’s True K’s TK value were significantly different from zero and all within ±0.25D.” On the preferred IOL, Dr. Fam said that in his experience, myopic refractive surgery tends to induce more spherical aberration. “Therefore a negative spherical aberration IOL is preferred,” he shared. “Generally, the calculated IOL SE power should be in the range of 12-24D,” he explained further. “In patients who want less spectacle dependency, it is advisable to avoid multifocal IOLs and monovision or extended depth of focus (EDOF) with micro-monovision are recommended.”
The road to successful cataract surgery in the postrefractive patients “We all know that corneal power is altered with laser refractive surgery and radial
CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
keratotomy,” said Dr. Mitchell P. Weikert, a professor at the Cullen Eye Institute, Baylor College of Medicine, Texas, USA. “The corneal power serves two roles in IOL calculation formulas,” he said. “It helps calculate the overall IOL power and helps predict where the lens will sit after the cataract surgery is completed. In most cases, corneal power is estimated from the anterior surface curvature, and the relationship between the anterior and posterior corneal surfaces changes after corneal refractive surgery.” Dr. Weikert emphasized the key preparatory steps needed in patient assessment. “The first thing to do is optimize corneal measurements,” he said. “Then, assess and manage ocular surface conditions, such as dry eye, epithelial membrane dystrophies, and nodular degeneration. There is also a need to assess corneal curvature for flattening and steepening.” For the preoperative assessment of postrefractive eyes, Dr. Weikert classified the different existing formulas for IOL calculation into three broad groups. “The first group consists of those that use the pre-refractive surgery K, and change in manifest refraction achieved with refractive surgery,” enumerated Dr. Weikert. “Then, there are those formulas that use only the change in manifest refraction and those in which no prior data is available. All these methods have been put together in the ESCRS postrefractive IOL calculator.” In addition, Dr. Weikert explained: “Intraoperative aberrometry may be beneficial in certain scenarios as it measures aphakic refraction after cataract removal and uses geometric optics to compute the IOL power, directly measuring the refractor effect of the cornea.” To conclude, he said: “There are, however, some disadvantages, which include the need to ‘guess’ the effective lens position and potential issues with speculum pressure, IOP, and wound hydration, which can affect the measurement”.
Cataract surgery after LASIK Meanwhile, Dr. Maria Jose Concertino
from Buenos Aires, Argentina, shared her experience in the management of cataracts in post-laser-assisted in situ keratomileusis (LASIK) eyes.
Eye Hospital in Bangalore, India. His session focused on cataract surgery and lens selection for patients who had phakic IOL.
“Cataract surgery after LASIK is associated with some challenging situations,” Dr. Concertino opened. “Firstly, consider the expectations and personality of the post-LASIK patient.”
In his presentation, he shared the clinical features of patients. “The incidence of cataracts following implantable contact lens surgery is currently about 1%-5%, and most cases present as anterior subcapsular cataracts,” he said. “Common causes include age >45 years, implantable collamer lens (ICL) power >-15D, low post-operative vault (<100 microns), and trauma.”
She added further stated: “In addition, calculation of the real power of the cornea, the effective lens position, and the type of IOL to be implanted all require careful evaluation.” According to Dr. Concertino, there are many advantages surgeons can derive from spending time in the preoperative preparation of patients to assess and manage expectations. “The preoperative examination includes detailed refraction, corneal topography and tomography, and determination of the axis of astigmatism,” she said. “We have to detect the presence of irregular astigmatism, evaluate the posterior corneal surface, and do a thorough corneal aberrometry.” In the same presentation, Dr. Concertino shared her recently published results. “In our center, our data showed that post-cataract surgery using Haigis-L formula in patients with previous LASIK, predictability of within ±1D in myopic cases was over 90%. However, in hyperopic LASIK, 85% was between ±1D.” She further explained: “Importantly, careful calculation of the IOL power with the available ASCRS online calculators is an essential element in reducing postoperative refractive surprises”. In conclusion, Dr. Concertino emphasized key steps: “To [place] accurate positioning of the incision to avoid edema at the flap or interface, and wait for a stable refraction to correct any residual ametropia,” she stressed.
Cataract surgery in patients with phakic IOL Dr. Sri Ganesh is the CEO of the Nethradhama Super Speciality
Dr. Ganesh presented a case of phacoemulsification after ICL. “I made a 2.8mm clear corneal incision with a 1mm side port incision and introduction of viscoelastic under the ICL,” he shared. “Thereafter, the ICL was gently nudged to allow the haptics into the anterior chamber.” He added that the incision was extended to 3.2mm and forceps was used to stabilize the haptic while the ICL is pulled through the incision. “Following explantation of the ICL, capsulorhexis was performed. With the cortex removed, the viscoelastic was introduced into the capsular bag. Following IOL centration in the bag, viscoelastic was aspirated and the wound was closed,” Dr. Ganesh shared. “Our experience so far shows that with careful preoperative evaluation, cataract surgery can be successfully carried out in eyes with phakic IOL,” he concluded.
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12 October 2021 | Issue #4
Tale of Two Centuries A short history of modern refractive surgery by Tan Sher Lynn
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ntroduced in 2018, the Heritage Lecture at the yearly Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) is aimed at highlighting important developments in the history of anterior segment surgery. This year, this prestigious award went to Dr. Patrick Condon from Ireland. Dr. Condon is the first to promote small incision surgery in Ireland in the early ‘80s and insert foldable silicone lens implant. He has received numerous awards, including the Montgomery Lecture University College Dublin 1998, ESCRS Grand Order of Merit Medal 1999, and Lifetime Achievement Award Lecture UKISCRS 2018.
A look back at the rich history of refractive surgery “One of the oldest surgical refractive procedures we have is the correction of astigmatism, with the surface of single case reports such as the ‘Animal Experimental Studies – In the Treatment of Astigmatism with Non-Perforating Corneal Incisions’, a paper by consultant surgeon Lans in 1896, which formed the basis of the corneal cupping effect,” said Dr. Condon as he started his presentation. In 1974, Russian ophthalmologist Svyatoslav Fyodorov developed the 16 metal blade radial keratotomy (RK) to correct myopia. Meanwhile, corneal lamellar refractive surgery began with José Barraquer from Spain who invented the microkeratome and cryolathe, which allowed him to perform refractive cuts
in the cornea, introducing the whole concept of keratomileusis.
the ‘Flap and Zap’ operation using the ACS with Summit Laser Stromal Ablation.
“However, the Barraquer microkeratome is technically difficult to use for surgeons and, therefore, was not adopted quickly,” said Dr. Condon. “But Luis Ruiz, also from Bagathar, developed the automated lamellar keratoplasty (ALK), which allowed a simultaneous primary cut of the cornea as the machine moved across it, as well as a stromal cut. Surgeons found this motorized and multi-geared device very useful and easier to use.”
In the same year in Dublin, Dr. Condon and O’Keefe were the first in the UK and Ireland to carry out this procedure.
The evolution of laser technology in refractive surgery In the ‘70s and early ‘80s, ultraviolet (UV) excimer laser technology was developed in Russia. A significant development was by Srinivason who demonstrated the effect of ablating minute amounts of surface tissue down to 0.000025 mm, using an ArFl-produced UV laser beam of 193 nm wavelength without any thermal effect. It was not long later that laser was combined with corneal lamellar refractive surgery to form laser in situ keratomileusis (LASIK). The first LASIK case was done by Buratto on October 25, 1989. In 1993, Stephen Slade introduced
As time went by, the microkeratome was gradually replaced by the femtosecond laser. This infrared solid-state laser operating at 1053 nm with ultrafast short pulses of 10-15s minimizes collateral tissue damage. The cutting process was driven by mechanical forces (bubbles) limited by focal spot size. “Today, the latest femtosecond laser can do both therapeutic procedures, such as keratoplasty, intracorneal implants, intracorneal ring tunnel, and keratoconus surgery, as well as refractive procedures like the femtosecond lens extraction (FLEx) and small incision lens extraction (SMILE),” he noted. Dr. Condon also talked about the evolution of other technologies, including corneal cross-linking for keratoconus, clear lens extraction for high myopia, anglesupported anterior chamber intraocular contact lens (IOL), posterior chamber IOL, intraocular contact lens (ICL), and iris fixated anterior chamber IOL. For his full presentation, view it ondemand at the ESCRS website.
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Overcoming Optical Obstacles Experts address common challenges in the treatment of geographic atrophy by Nick Eustice
This study, Dr. Sarici said, can form the basis for future studies utilizing the most important predictive parameters. In so doing, she believes it will be possible to achieve more meaningful results in a shorter time by including the identified high-risk patients in these studies.
Reasons why patients fail to follow up treatments Turning to another issue of concern in the area of GA, the next speaker, Dr. Durga Borkar, addressed the problem of patients who were lost to follow-up (LTFU). Sadly, a large percentage of GA patients choose to abandon treatment options. This can be for various reasons, such as treatment cost, the difficulty of access to clinical practice, or a lack of treatment options. Using data from the IRIS Registry, Dr. Borkar identified 57,788 patients who were LTFU within two years of diagnosis, and 84,686 with more than two years of follow-up out of a total sampling of 230,174. Seeking to find out why this may be, Dr. Borkar identified several distinguishing characteristics which LTFU patients had in common.
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eographic atrophy (GA) is one of the most challenging issues in retinal science. An advanced form of dry age-related macular degeneration (AMD), GA affects close to 1 million people in the United States and over 5 million worldwide. The challenges presented by GA are diverse. In addition to a general lack of treatment options available, it is also very difficult to predict. This, in turn, makes it difficult to identify a target population and a target area for future drugs. In addition, as a result of its relatively few treatment options, it is difficult to maintain contact with GA patients for whom future drug trials could be of substantial benefit. Yesterday, two speakers during the Dry AMD Symposium at the American Society of Retina Specialists (ASRS 2021) Scientific Meeting presented new uses for information technologies in addressing some of the challenges posed by GA.
The potential use of smart OCT in early detection of GA The first speaker, Dr. Kubra Sarici, spoke on the potential of smart optical coherence tomography (OCT) for use in detecting early signs of GA. In her lecture, “Machine Learning Enabled Outer Retinal OCT Biomarker Extraction for Identification of High-Risk AMD Eyes for Subfoveal Geographic Atrophy Progression”, Dr. Sarici presented results from a study where her research team utilized longitudinal analysis and Random Forest Regression algorithms to detect correlations between instances where GA progressed into the patient’s foveal center. By integrating selection parameters into a classification model, the artificial intelligence (AI) program was able to develop a highly discriminating prediction model. This model can be of great benefit in identifying cases where patients are at greater risk of developing GA-related vision loss.
LTFU patients were on average 3.7 years older than those who remained in the care of an ophthalmologist. They also had a slightly higher proportion of Medicaid or uninsured patients. In addition, the study found that LTFU patients who had shorter follow-up times were less likely to be managed by a retina specialist than by an optometrist or general ophthalmologist. Visual acuity was also a significant factor associated with LTFU. The greater the visual loss that resulted from the patient’s GA, the more likely the patient was to abandon treatment. On the other hand, where patients had a concomitant condition, such as glaucoma or cataracts, they were far less likely to be LTFU. Dr. Borkar concluded by saying that there remains a tremendous unmet medical need in GA, as evidenced by the frequency with which GA patients are lost to follow up in clinical practice. With potential GA treatments on the horizon, appropriate management and follow-up of GA patients are of the utmost importance.
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12 October 2021 | Issue #4
Patient self-operated Notal Home OCT (Notal Vision Inc.)
Something to Smile About Home OCT takes a step forward with results from first U.S. longitudinal study by Brooke Herron
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e know that regular monitoring of patients with neovascular age-related macular degeneration (nAMD) is critical to preventing disease progression. However, this results in frequent office visits for OCT scans and treatment, which can be burdensome for patients, caregivers, and physicians, alike. An additional obstacle for these elderly patients is the ongoing COVID-19 pandemic, as many are not overly keen to attend regular in-person office visits for fear of contracting the virus. Therefore, eyes (pun intended) are turning toward home monitoring. “We know that the majority of patients with nAMD need a caregiver to go to the doctor’s office which sometimes limits their ability to see the doctor and receive treatment,” shared Dr. Kester Nahen, Ph.D., CEO of Notal Vision, Inc.
“By monitoring the patients at home and seeing the doctor when they need treatment, that lessens the burden on the patient — which increases the willingness of patients to stay on therapy longer and thus, maintain vision.” And, fortunately, there is a solution on the way — thanks to Notal Vision (Manassas, VA) and its investigational Home OCT system, which provides patient-initiated retinal OCT scans. This user-friendly device allows for daily disease monitoring to continue from the comfort of patients’ homes and complements the existing standard of care in treatments, as well. Although this device is not yet cleared by the FDA, it’s well on its way, thanks to continued study and positive results and outcomes. Indeed, data from the first U.S.-based Home OCT feasibility study, Prospective
Longitudinal Study: Fluid Quantification From Daily Self-imaging With Home OCT in Neovascular Age-Related Macular Degeneration, were presented by Jeffrey S. Heier, MD, from Ophthalmic Consultants of Boston, Massachusetts, USA, to an engaged audience at the American Society of Retina Specialists (ASRS 2021) Scientific Meeting.
The study says... The study was conducted by Dr. Heier, along with co-investigator Nancy Holekamp, MD, from Pepose Vision Institute, St. Louis, Missouri, USA, with the aim of evaluating patients’ ability to perform sequential, daily self-imaging of their eyes. The investigators also looked into the patients’ ability to set up the device, the telemedicine infrastructure for secure and automated data uploading,
CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
and the deep learning algorithm (the proprietary Notal OCT Analyzer, NOATM) for fluid quantification. Dr. Heier and Dr. Holekamp also observed disease dynamics and treatment responses. The three-month study took place at the two investigators’ practices and included 29 eyes from 15 nAMD patients with a mean visual acuity (VA) of 20/40 (with a range of 20/20 to 20/200). Twentythree eyes had been diagnosed with nAMD and six with dry AMD, with one eye converting to nAMD during the study. The main outcome measures were the daily self-imaging completion rate, duration of the self-imaging process, image quality, agreement between automated and human grading of retinal fluid, and temporal dynamics of intra- and subretinal fluid volume. “Over 2,300 images were evaluated: 96% of all images were able to be completed, the mean duration for self-imaging was 40 seconds, and on average patients performed 5.7 scans per week,” shared Dr. Heier. During the study, the median self-imaging time decreased from 45.4 to 38.0 seconds, showing progressing patient proficiency in self-operation of the device. During the study, patients’ weekly scan frequency remained consistent over the three-month study, and subjects who did not self-image for two consecutive days received a compliance reminder call from the Notal Vision Monitoring Center, the future provider of the Home OCT monitoring service. “The overall [subjective] patient experience was excellent, with a
grade of strongly agree or agree on all parameters,” he continued. In the image quality assessment, readers determined that an image quality index of 2 or greater was sufficient to be able to grade these images, and 97% of all scans had an index of 2 or greater, said Dr. Heier. Further, 93% of scans (n=2,208) met the criteria for the NOA AI algorithm to perform fluid quantification. Both Dr. Heier and Dr. Holekamp reviewed the images weekly and compared them against the artificial intelligence (AI) interpretation. There was an 83% agreement between AI-based and investigator grading for presence or absence of fluid; there was a 17% disagreement, but the majority of these were where the investigator determined subtle, trace, or no fluid, said Dr. Heier. Subretinal fluid volume was measured in nano-liters, which allowed for very accurate tracking of disease activity over time. He continued that using subretinal fluid volume trajectories gives insight into disease dynamics and treatment response — highlighting heterogeneity across the study population. “This gives us the opportunity to look at numerous parameters for fluid volume dynamics,” said Dr. Heier. These include fluid volume at the time of treatment, time to 50% reduction in fluid volume after treatment; weekly fluid decrease after treatment; minimum fluid volume between treatments; and area under the fluid volume curve between treatments.
self set-up and self-imaging with Home OCT was achieved with a high level of adherence and a positive patient experience. “Up to daily self-imaging provided images of satisfactory quality for human grading and AI-based analysis and gave an analysis of trajectories of fluid volume over time,” he continued “Parametric description of fluid volume trajectories may support disease and treatment response classification — it will especially do this as we look at the development of sustained drug delivery and other extended durability treatments.”
Added benefits for patients and physicians In addition to reducing treatment burden, the Home OCT may also shed light on what exactly happens between office visits. “We know that treatment outcomes in the real world do not match the results of randomized controlled trials … and that’s mainly because of undertreatment,” explained Dr. Nahen. The Home OCT could explain why some of this is happening — as well as provide crucial data to doctors. “We’re getting great insight into what happens between office visits — we can truly say whether the patient responded to therapy, how quickly they responded, when exactly the fluid reoccurs in the retina, and how fast it recurred. So, we get a much better description of disease activity and treatment response. These new insights will help to better personalize the therapy,” said Dr. Nahen.
Overall, Dr. Heier shared that successful Another perk for physicians who refer their patients to the monitoring center lies in reimbursement, which they will be able to bill for the review of remote OCT data and images every 30 days. A final key point raised by Dr. Nahen was on the relationship between AI and physicians.
AI-based analysis of daily Home OCT provides insights in temporal subretinal fluid (SRF) volume dynamics between office visits and illustrates fluid exposure to the retina in eyes managed with treat and extend protocol. (Notal Vision Inc.)
“The use of new device technology and AI is still a physician-led process — it doesn’t take away responsibility or tasks from the physician, it actually enables them to manage the large amounts of data that such a remote OCT technology produces. Thus, AI is the friend to the retinal specialist and it does not replace humans,” he concluded.
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CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
long-term efficacy, as well as safety data, on agents that are currently approved,” he said. “I don’t plan to use them and, hopefully, as a community, we will not be forced to use them because I think we have to put our patients first.” So, is there anything that could convince those like Dr. Khanani to use these biosimilars?
Hot Topic in AMD
Biosimilars — To use or not to use? by Brooke Herron
A
s the media, we’re always here for a good panel discussion. And the American Society of Retina Specialists (ASRS 2021) Scientific Meeting didn’t disappoint in this regard during its short session on Hot Topics in Wet and Dry AMD. Led by Dr. Peter Kaiser, panelists included Dr. Diana Do, Dr. Arshad Khanani, and Dr. David Eichenbaum, who all contributed to the vibrant conversation on various topics. One such discussion focused on biosimilars, which Dr. Kaiser explained are not generic agents — rather, they are similar to the reference product.
On bevacizumab biosimilars Let’s face it — whether you’re a patient or physician — dealing with insurance companies is rarely a walk in the park. And now that some of these biosimilars are gaining the Food and Drug Administration (FDA) approval, Dr. Kaiser asked if the panelists had any issues, or had been required, by insurance carriers to use bevacizumab biosimilars.
According to Dr. Eichenbaum, his practice did receive a letter from an insurance carrier that encouraged them to utilize bevacizumab biosimilars. “We very quickly responded to that letter and explained that we do not have any sort of volume of data — or actually anything — regarding the use of a repackaged bevacizumab biosimilar for intravitreal use,” he explained, adding that this quickly solved that problem for his practice. (Final score: Physicians 1, Insurance Carriers 0)
On ranibizumab biosimilars Next up on the chopping block were ranibizumab biosimilars, of which one is FDA approved and two have passed phase 3 studies, noted Dr. Kaiser. Thus, he wondered how the panel planned to incorporate these into their treatment paradigms. A straight-shooter, Dr. Khanani simply said that he doesn’t see how a ranibizumab biosimilar would fit into his practice. “Remember, it’s all about taking care of your patients and we have
“I think retina specialists are very concerned about both efficacy and safety, so showing us data would help compel us to either use them or not,” answered Dr. Do. “Simply because our current FDAapproved agents have such a long track record of safety and efficacy over years of follow-up — and that’s what makes us comfortable prescribing and using these agents in our patients.”
When repackaging becomes illegal This discussion made it pretty clear that retinal specialists — or at least those on this particular panel — are not overly keen to switch over to biosimilars. However, if approved, there could be additional challenges faced by those who currently use off-label bevacizumab as a first-line therapy. As noted by Dr. Kaiser: “Once a drug is FDA-approved, compounding that drug no longer can occur, it becomes illegal. So what may happen if the bevacizumab biosimilar is approved?” He then explained that it will depend on what the FDA does and what’s required from a legal standpoint. “The reason I use bevacizumab is simply price — so once that price difference disappears, then many of my reasons for using it disappear as well,” shared Dr. Kaiser. Another concern, according to Dr. Eichenbaum, is that repackaged bevacizumab may no longer be available following FDA approval of the biosimilar. Further, its approval will only be on-label for wet age-related macular degeneration (AMD). “I worry about access for our patients who may not have neovascular AMD and for our physicians who rely on repackaged bevacizumab for treating their patients, and allowing continued care with the low-cost, easy-access agent,” he summed up.
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12 October 2021 | Issue #4
Peel and Restore Extraordinary studies and experiments for successful macular hole repair by Olawale Salami
T
he buoyancy effect of intraocular gas has long been proposed to be critical to successful macular hole repair. Recent studies have suggested the role of internal limiting membrane (ILM) peeling in the successful closure without facedown positioning. Dr. Keith A. Warren, a professor of ophthalmology at the University of Kansas, and colleagues analyzed a retrospective consecutive case series
of patients treated with pars plana vitrectomy, ILM peel, and gas tamponade without face-down positioning. Their study was presented yesterday at the American Society of Retina Specialists (ASRS 2021) Scientific Meeting.
Don’t face down Dr. Warren and his colleagues analyzed data from 35 eyes in 33 patients
diagnosed with stage 3 or 4 idiopathic macular hole between 2016 and 2019. “A single surgeon treated the eyes with 23 gauge pars plana vitrectomy, ILM peel, and SF6 gas tamponade,” he shared. “Phakic patients underwent combined phacoemulsification and vitrectomy surgery.” The study excluded patients with other ocular comorbidities, such as previous vitrectomy or traumatic macular holes.
CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
Dr. Warren continued: “Patients were instructed not to position face down but were permitted to assume any position except supine,” he said. On patient follow-up, Dr. Warren said, “We followed up patients for an average duration of 18 months. After which, we evaluated the primary outcome, which was the successful closure of the macula hole by a single operation. Other variables evaluated include visual acuity and diameter of the macular hole.”
“This study may suggest that ILM peel plays an important role in macular hole closure, not gas tamponade.” — Dr. Keith A. Warren, University of Kansas No major complications here
In the study, there were 25 female and 10 male patients, and the mean age of patients was 72.3 years. “There were 21 right eyes (60.0%) and 14 (40.0%) left eye,” shared Dr. Warren. “About half of the eyes (57.1%) eyes underwent combined phaco-vitrectomy. Mean pre-operative vision was 0.64 LogMar with a mean post-operative vision of 0.14 LogMar. The average pre-operative macular hole diameter was 520 +/197 µ.” He added that 32 of 35 eyes closed with a single operation. “Early posterior capsular opacity was noted in three eyes that underwent combined phaco-vitrectomy,” he said. “No other complications were reported. While the average hole base diameter (BD) of the three eyes was 935 μ , there was no statistically significant relationship between the diameter of the macula hole, duration of symptoms, or lenticular status and hole closure.” Eyes that underwent combined phacovitrectomy had a slightly decreased final vision when compared to those who underwent vitrectomy alone, but this difference was not statistically significant, according to Dr. Warren.
It’s all about the ILM peel
“The primary macular hole repair without face-down positioning was successful in 91% of eyes,” enthused Dr. Warren. The average hole base diameter and duration did not have a significant effect on the successful repair. Visual acuity improvement was associated with hole closure, a shorter period (< 6 months), and smaller BD (<400 µ). “This study may suggest that ILM peel plays an important role in macular hole closure, not gas tamponade,” he explained.
“We believe that the proteome of proliferative vitreoretinopathy tissue, with a particular focus on those proteins differentially expressed in the ERM, will help us to understand the mechanism of disease better and identify therapeutic targets,” shared Dr. Miller. Preretinal tissue delaminated during pars plana vitrectomy for RD with PVR or idiopathic ERM was collected from nine patients. These were processed and analyzed by mass spectrometry.
“We believe that the proteome of proliferative vitreoretinopathy tissue, with a particular focus on those proteins differentially expressed in the ERM, will help us to understand the mechanism of disease better and identify therapeutic targets.”
The symphony of protein expression in preretinal tissue Proliferative vitreoretinopathy complicates 5% to 10% of retinal detachments. While it has been identified as a cause of recurrent retinal detachment, its underlying molecular pathogenesis remains poorly understood. Dr. Charles Miller, a clinical fellow in ophthalmology at the Scheie Eye Institute at the University of Pennsylvania, is trying to unravel the protein expression patterns of preretinal tissue in patients with proliferative vitreoretinopathy and epiretinal membrane (ERM). Working with colleagues, Dr. Miller designed experiments aimed at characterizing the proteome of preretinal membranes delaminated during surgery for retinal detachment with proliferative vitreoretinopathy (PVR) in comparison to idiopathic ERM. A stu
dy suggests ILM
peel p
l ay s a n
— Dr. Charles Miller, Scheie Eye Institute, University of Pennsylvania Discovering a world of data
“We discovered that the proteome consists of 1119 proteins, which by principal component analysis and hierarchical clustering, delineated a proteomic signature,” explained Dr. Miller.
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He added: “Idiopathic ERM proved more heterogeneous than anticipated, and gene-set enrichment analysis revealed four biological processes from the gene ontology database that are overrepresented in proliferative vitreoretinopathy. These are extracellular matrix organization, extracellular structure organization, supramolecular fiber organization, and cytoskeleton organization.”
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12 October 2021 | Issue #4
The protein with the highest relative mean spectral counts in analyzed tissue is fibronectin, a multidomain, extracellular matrix glycoprotein. According to Dr. Miller, “We then compared proteins from proliferative vitreoretinopathy tissue with those from the ERM by foldchange analysis. We identified a set of 186 proteins, 42 of which are components of the matrisome (ECM-related proteins).”
Into the matrix
Additional analyses revealed that extracellular matrix components were enriched in preretinal tissue derived from proliferative vitreoretinopathy cases. “These data emphasize the importance of the fibrotic (acellular) component of PVR membranes,” explained Dr. Miller. “The extracellular matrix expression profile of proliferative vitreoretinopathy tissue differs significantly from that of idiopathic epiretinal membrane,” he added. “These insights support a novel therapeutic strategy aimed at inhibiting extracellular matrix assembly, preventing proliferative vitreoretinopathy, and subsequent retinal detachment.”
Rise of the machines: Deeplearning algorithm in the diagnosis of macular holes Artificial intelligence (AI) and deeplearning tools can improve diagnostic accuracy and clinical efficiency in detecting various ocular disease states. Dr. Jessica L. Cao and colleagues at the Cole Eye Institute, Cleveland, Ohio, evaluated the feasibility of deep-learning (DL) algorithm to detect macular holes (MH) and related pathological findings on optical coherence tomography (OCT).
“The purpose of our study was to validate the reliability of a DL algorithm for MH and MH-related pathologies on OCT as a potential screening aid in the clinical setting,” explained Dr. Cao.
“The purpose of our study was to validate the reliability of a DL algorithm for MH and MH-related pathologies on OCT as a potential screening aid in the clinical setting.” — Dr. Jessica L. Cao, Cole Eye Institute, Cleveland, Ohio
She and colleagues conducted a retrospective study of patients of at least 18 years of age who were diagnosed with MH, and patients were excluded if they were diagnosed with any concomitant maculopathy.
“A total of 346 OCT macular cube scans from eyes with a diagnosis of MH and 307 control scans without any vitreomacular pathology were included,” Dr. Cao shared. “Two human graders analyzed all scans for the presence of pathologies, such as subretinal or intraretinal fluid, disturbance of vitreoretinal interface, or IS/OS disruption. The algorithm then graded all scans based on a set scale. The grading results of the algorithm and the two human graders were then compared to determine the level of agreement.”
Man vs. algorithm
Dr. Cao explained the study results: “When we compared human grader 1 to the algorithm, there was an 86.17% rate of agreement for the detection of any pathology on the scan. For human grader 2 versus the algorithm, there was an 87.83% agreement rate,” she remarked. “When combining the results of the two graders and at least one grader marked the macular cube as abnormal, there was an 87.61% agreement rate.” In conclusion, she said, “Deep-learning algorithms may be reliable tools for the early detection of macular holes on OCT and, by extension, could be useful screening aids that help improve clinical efficiency”.
CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
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12 October 2021 | Issue #4
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CAKE and PIE magazines’ Daily Congress News on the Anterior and Posterior Segments
Like Apples and Oranges Not all clinical studies are created equal — Watch out for disparities! by Nick Eustice
W
e live in the information age, and our lives and practices revolve around an ever-increasing flow of data. This data comes from many different sources. However, when we are concerned with cutting-edge treatments and statistics on disease management, the primary sources of our information are clinical studies. The reason for this should be obvious, as these studies utilize the scientific method to simulate the real world. Researchers try to achieve the purest, most direct results possible, by controlling conditions and collecting data in the lab. Clinical studies are so reliable, and so commonly accepted, that we rarely, if ever, question their applicability to the real world.
How reliable are clinical studies? Sometimes, however, it’s important to pause, and consider how relevant the most objective of studies are. Because as hard as we may try to simulate the real world in a lab, in the end, the lab is not the real world. Such was the topic of Dr. Franco Recchia’s lecture yesterday at the American Society of Retina Specialists (ASRS 2021) Scientific Meeting, entitled “Apples and Oranges: ‘Real-World’ Outcomes Differ from Clinical Trial Outcomes Because ‘Real-World’ Patients Differ from Clinical Trial Patients”. As the title implies, the main difference between the real world and the lab — which he chose to address in this lecture — was the patients themselves.
“Several real-world studies in wet age-related macular degeneration (AMD) have been published over the past several years, and nearly all of them come to the same conclusion: that in the real world, patients are undertreated and have clinical outcomes worse than expected,” shared Dr. Recchia. Clearly, this is a major concern for clinicians and researchers alike. Thus, Dr. Recchia set out to address his fundamental question: is there a difference in clinical treatment and visual outcome between real-world patients who would have been eligible for clinical trials and real-world patients who would not have been eligible for clinical trials?
Be wary of baseline discrepancies To answer this question, Dr. Recchia and his colleagues reviewed all patients in their community retinal practice over a two-year period. They identified a sampling of all patients with a new diagnosis of active choroidal neovascularization (CNV) in neovascular age-related macular degeneration (nvAMD) by ICD-10 code. They then analyzed the clinical data and imaging for each patient, and applied the inclusion and exclusion criteria for each of the
major AMD trials. In so doing, they ascertained the eligibility of all of their patients for all of these trials. The results were immediately quite striking: most of their patients were simply ineligible for the trials. This was due to a number of reasons, mainly either vision characteristics and prior treatment. The result of this eligibility was a very significant discrepancy, with eligible patients showing far better visual change, receiving more injections, and were more likely to receive overall visual care. So what does this tell us? Dr. Recchia concluded that most real-world patients do not reflect the profile of patients in clinical trials. And these trials are what inform our standard of care and serve as benchmarks. Real-world patients can achieve similar outcomes to those reflected in studies, but only, as Dr. Recchia noted, when we compare “apples with apples”. He closed by noting that when we are acquiring the data, and writing the papers, we must always remember the baseline disparities that can affect our conclusions.
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