CERSI Collaborators: Kuldev Singh, MD, MPH
FDA Collaborators: Malvina Eydelman, MD, Michelle Tarver, MD, PhD (CDRH)
Project Start Date: September 2015
Regulatory Science Challenge
Glaucoma, a chronic eye disease that results in damage to the optic nerve and can potentially lead to blindness, affects over 2.7 million Americans. Increased pressure inside the eye is a contributing factor to glaucoma progression. Therefore, therapies such as eye drops, oral medications, laser therapy, and surgery are designed to lower this pressure. Recent innovation in glaucoma procedures has led to the development of minimally invasive glaucoma surgical (MIGS) devices, which may be safer than other glaucoma surgical procedures and reduce the need to use eye drops. Previously, evaluation of new devices by the FDA has not adequately included information provided by glaucoma patients, such as health-related quality of life, function, and eye symptoms. Patient reported outcomes can provide insights about how patients feel and function with their medical conditions. Patient reported outcomes, collected through the use of reliable and valid questionnaires can enhance regulatory reviews and post-market evaluations. A collaborative effort between FDA, UCSF-Stanford CERSI, JHU CERSI and the American Glaucoma Society has been established to develop a patient-reported outcome measure that can capture information on symptoms and functioning from glaucoma patients for MIGS devices.
Project Description & Goals
The goal of this project is to develop a tool, or patient-reported outcome measure (PROM), that can be included in FDA submissions for MIGS devices, as well as answer important questions related to glaucoma therapy from the patient’s perspective. Focus groups and interviews will be conducted to qualitatively assess health-related quality of life in patients with mild to moderate glaucoma and to construct the questionnaire. The questionnaire will be available to researchers to assess its measurement properties and to ultimately capture the impact of treatment on quality of life metrics. This information, along with further input from physicians/ carepartners, researchers, regulators, and AGS, will be used to develop the questionnaire, which will ultimately be available online for public use.