Verana Health, along with the FDA, the American Glaucoma Society, and American Academy of Ophthalmology, recently announced the launch of the Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery study with the first patient enrolled.
Verana Health, along with the FDA, the American Glaucoma Society, and American Academy of Ophthalmology, recently announced the launch of the Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery (PRO-MIGS) study with the first patient enrolled.
The aim of the study is to develop a patient-reported tool that can measure health-related quality of life both before and after minimally invasive glaucoma surgery (MIGS), according to a Verana statement. Currently, more than 2.7 million Americans are affected by glaucoma, a chronic eye disease that can damage the optic nerve and potentially lead to blindness.
PRO-MIGS also includes the FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSIs). Together, the partners will develop the PRO instrument, Glaucoma Outcomes Survey, or GOS, that can be used for future FDA submissions for MIGS devices.
“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,” the statement reads. Intraocular pressure is a contributing factor to glaucoma progression.
Before the development of MIGS, therapies such as eye drops, oral medications, laser therapy, and surgery were used to address this pressure. MIGS devices may be safer than other surgical procedures and reduce the need to use eye drops, the FDA reports.
According to the Glaucoma Research Foundation, traditional glaucoma surgeries carry the risk of double vision, eye infections, exposure of a drainage implant, swelling of the cornea, and excessively low intraocular pressure. Although these complications are less frequent, most surgeons will delay surgery until all other less invasive treatment options have been exhausted and the patient’s glaucoma has definitively worsened.
Up to 500 patients will be enrolled in the study, which will include administering the GOS before and after the MIGS procedure.
To identify potentially eligible patients for the study, Verana Health analyzed real-world data from the electronic health records of ophthalmology practices across the country. Leveraging these data, the company will identify sites that frequently perform MIGS and have a demographically diverse population of patients with glaucoma.
“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,” explained Don Nguyen, MD, a glaucoma specialist and surgeon from BVA Advanced Eye Care in Oklahoma City, in the statement.
“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,” Nguyen said.