New patient-reported outcomes validation study enrolls first participant
The first patient has been enrolled in the Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery (PRO-MIGS) study, according to a press release by Verana Health.
In addition to Verana Health, 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) will collaborate on the project to develop the Glaucoma Outcomes Survey (GOS), a patient-reported outcome tool to measures health-related quality of life before and after MIGS.
The GOS could be used for future MIGS device submissions to the FDA.
“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 in a press 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.”
Read the full press release here.