Verana Health announced the start of the Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery (PRO-MIGS) study with the first participant enrolled. The project, which also includes the U.S. Food & Drug Administration’s (FDA), Center of Excellence in Regulatory Science and Innovation (CERSI) from UCSF and Stanford, American Academy of Ophthalmology (Academy), and American Glaucoma Society (AGS) as partners, will develop a patient-reported outcome (PRO) instrument called the Glaucoma Outcomes Survey (GOS) that can be used for future FDA submissions for MIGS devices, as well as answer important health-related quality of life questions for the 2.7 million Americans affected by glaucoma.
The GOS study will enroll up to 500 patients and will collect data from participants by administering the GOS before and after the MIGS procedure.
Leveraging data from the Academy’s IRIS Registry (Intelligent Research in Sight), Verana Health analyzed real-world data (RWD) sources from the electronic health records (EHRs) of ophthalmology practices across the U.S. to identify potential study sites that frequently perform MIGS surgeries and also have a demographically diverse population of glaucoma patients. Verana Health will deploy ”Verana Trial Connect” software at sites utilizing IRIS Registry data to identify and prioritize potentially eligible patients and support more efficient enrollment processes.
“We are proud to be able to undertake and sponsor this comprehensive, cutting-edge research study in collaboration with leaders from the FDA’s Center for Devices and Radiological Health (CDRH), Academy, AGS, and the CERSI group from Stanford and UCSF,” Matthew Roe, MD, MHS, Chief Medical Officer at Verana Health, said in a company news release. “Recruiting and enrolling glaucoma patients at the ideal time during their course of treatment—before MIGS surgery—can be difficult. Verana is using its advanced data analytic capabilities and software tools to address these challenges to facilitate a more comprehensive, patient-centric evaluation of the validity of the GOS for patients undergoing MIGS surgeries.”
Don Nguyen, MD, Glaucoma Specialist and surgeon from BVA Advanced Eye Care in Oklahoma City commented: “Previous MIGS studies have primarily focused on outcomes — such as change in intraocular pressure, glaucoma medication reduction, and visual field stability — to determine success. While these parameters are imperative for clinical success and disease stability, they don’t provide insight into how the patient’s daily life might change post-operatively. For the first time, the Glaucoma Outcomes Survey will focus on the patient experience and how microinvasive glaucoma surgeries impact their day-to-day life. I believe the results from this study can be used by physicians to better counsel patients when discussing what improvements they can expect post-operatively from MIGS procedures that are performed with their cataract surgery.”
Ron D. Hays, Professor of Medicine, Professor of Health Policy and Management, and affiliated adjunct researcher at the RAND Corporation added: “This field test of the Glaucoma Outcomes Survey will result in a state-of-the-science patient-reported outcomes measure that is freely available to use for assessing patient-reported outcomes of minimally invasive glaucoma surgery.”