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 will develop a patient-reported outcome 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 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 MIGS procedures.
Leveraging data from the AAO’s IRIS Registry, Verana Health analyzed real-world data sources from the electronic health records of ophthalmology practices across the United States to identify potential study sites that frequently perform MIGS and also have a demographically diverse population of glaucoma patients.
“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 analytics 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,” said Matthew Roe, MD, MHS, Chief Medical Officer of Verana Health, in a news release.
Don Nguyen, MD, glaucoma specialist and surgeon from BVA Advanced Eye Care in Oklahoma City, said, “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 postoperatively. For the first time, the Glaucoma Outcomes Survey will focus on the patient experience and how microinvasive glaucoma surgeries impact their day-to-day lives. I believe the results from this study can be used by physicians to better counsel patients when discussing what improvements they can expect postoperatively from MIGS procedures that are performed with their cataract surgery.”