Study on patient-reported outcomes for MIGS underway
Verana Health has enrolled the first subject in the Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery study, according to a press release.
The goal of the PRO-MIGS study is to develop the Glaucoma Outcomes Survey (GOS), a patient-reported outcome instrument that may be used for future FDA submissions of MIGS devices, the release said.
The FDA’s Center of Excellence in Regulatory Science and Innovation, the American Academy of Ophthalmology and the American Glaucoma Society are partners in the project.
“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,” Matthew Roe, MD, MHS, chief medical officer at Verana Health, said in the release.
Up to 500 patients are expected to be enrolled, with data collected before and after their MIGS procedure.