Verana Health, FDA, CERSI, the American Academy of Ophthalmology and the American Glaucoma Society Announce the Start of a New Patient-Reported Outcomes Validation Study
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Program aims to develop a patient-reported outcome tool that measures health-related quality of life before and after minimally invasive glaucoma surgery
San Francisco, CA — December 16, 2020 — Verana Health, a healthcare technology company focused on curating and analyzing health care data to advance medical research and patient care, today 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.
Similar to standard invasive glaucoma surgeries, MIGS is a group of surgeries that aim to lower intraocular eye pressure to prevent or reduce damage to the optic nerve and to preserve vision. To reduce the incidence of potential complications, MIGS surgeries use microscopic-sized devices and small incisions to achieve the desired surgical result. 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,” said Matthew Roe, MD, MHS, Chief Medical Officer at Verana Health. “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.”
About Verana Health
Verana Health partners with leading medical associations to transform clinical data into actionable real-world evidence. These partnerships enable Verana to harness the comprehensive data found in qualified clinical data registries and other specialty data sources to accelerate medical research and enhance patient care. Learn more at veranahealth.com.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit aao.org.
About the Center of Excellence in Regulatory Science and Innovation from Stanford and UCSF
The Center of Excellence in Regulatory Science and Innovation (CERSI) is a joint effort among members of a world-class team of highly collaborative scientists at UC San Francisco, Stanford University, and the U.S. Food and Drug Administration (FDA). The two academic institutions and the FDA work together on projects that promote regulatory science—including innovative research, education, and scientific exchange—in partnership with foundations and commercial entities. The center collaborates, in particular, with the pharmaceutical, biotechnology, and high-tech industries of the San Francisco Bay Area and the West Coast.
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (Center of Excellence in Regulatory Science and Innovation grant to the University of California, San Francisco (UCSF) and Stanford University, U01FD005978) totaling $304,861 (77 percentage) funded by FDA/HHS and $89,177 (23 percentage) funded by a non-government source. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.