SPOTLIGHT ON TECHNOLOGY & TECHNIQUE BY KAREN APPOLD, CONTRIBUTING EDITOR
IMPROVING CLINICAL TRIAL ACCURACY
IMAGE COURTESY: M&S TECHNOLOGIES
M&S Technologies’ DVA-5000 delivers unbiased data.
FIGURE. M&S’s DVA-5000
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linical researchers have a new tool with the launch of the M&S Technologies Clinical Trial Suite (CTS) DVA-5000 module. This computerized system integrates validated M&S Technologies’ visual acuity testing algorithms for use in clinical trials and research. The module provides computer-automated Early Treatment Diabetic Retinopathy Study (ETDRS),
Electronic Visual Acuity (EVA) and contrast sensitivity (CS) testing. “We created the DVA-5000 for retina and glaucoma researchers, clinical trial sponsors and private practice research clinicians who require consistent, unbiased test results from visit to visit and site to site,” says Joseph Marino, MBA, BS, founder and global head of M&S Technologies, Niles, Ill. CTS has been used in more than 140 ophthalmic clinical trials, and the FDA recognizes it as an acceptable method of vision testing in all phases of clinical trials, including PMA trials. CTS testing modules offer stateof-the-art diagnostic technologies and digital monitoring systems for studying medications, the company says. “As a principal investigator, I have used CTS testing modules in presbyopia and IOL trials per sponsors’ requests,” says David Evans, OD, president of Total Eye Care, PA, in Memphis, Tenn. HOW IT WORKS The DVA-5000 was designed to meet the needs of sponsors of retina and glaucoma clinical trials by improving ETDRS test accuracy and including contrast function testing that is accurate, validated and time-saving. Retina and glaucoma subspecialty trials may include testing such as optical coherence tomography, visual fields, IOP measurements and photography. “Although these trials include visual
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acuity testing, sponsors aren’t aware of the speed, accuracy and efficiency of CTS, ETDRS, EVA and CS testing,” says Joseph P. Gira, MD, at Ophthalmology Consultants in St. Louis, who also uses the DVA-5000. “There is evidence1-4 that CS testing documents changes in neovascular AMD, intermediate AMD, branch retinal vein occlusion and glaucoma. CTS CS testing is fast and accurate, or it wouldn’t be used in so many trials.” All testing on the DVA-5000 is preprogrammed to meet the requirements of the sponsor, researcher or investigator site. Test results with customized analysis are available in formatted letter score, logMAR, decimal score and Snellen equivalent. Sponsor-customized reports are secure, encrypted and immediately available for export or upload to an electronic data capture site (EDC) in .XML or .CSV formats. A customized preprogrammed control tablet is Bluetooth connected to the DVA-5000 system with protocol requirements. Tablet instructions guide technicians through all aspects of testing for a trial’s duration, Dr. Evans explains. Test data is entered directly to the tablet, saving time compared to using a standard light box with paper test-score documentation. Technicians cannot deviate from the protocol, which has caused trial errors previously, he notes. The tablet allows for easy data entry based on a subject’s responses and a reaffirmation point to verify the entered data, Mr. Marino says. The technician simply enters the number of letters that are correct as the subject advances through the ETDRS chart. The DVA5000 eliminates manual calculations, all data entry and technician bias. It can be configured for automatic test result uploading. ADVANCED AND INNOVATIVE According to Mr. Marino, CTS modules, including the DVA-5000, are popular among clinical trial sponsors
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