By Kristen Mulvihill
Scheie Vision Summer 2020
Qi N. Cui, MD, PhD, Assistant Professor of Ophthalmology at the University of Pennsylvania, and collaborators recently created a questionnaire targeted towards patients eligible to receive a novel type of glaucoma surgery.
Glaucoma—a group of diseases that slowly damages the optic nerve—is the leading cause of irreversible blindness worldwide. It can cause permanent loss of the visual field, usually due to high pressure inside the eye. Unlike many other ocular conditions, glaucoma is a silent disease, with symptoms often undetected until late in the disease.
If diagnosed early, glaucoma has several effective treatment options designed to slow disease progression by lowering pressure inside the eye (i.e. intraocular pressure). Some of the standard glaucoma surgeries, including trabeculectomy and tube shunt procedures, are often effective at lowering intraocular pressure and preventing damage to the optic nerve. However, because these surgeries often involve manipulation of multiple components of the eye, they pose risks for potential vision-related complications.
Recently developed and rapidly evolving, minimally invasive glaucoma surgery (MIGS) is a group of procedures known to reduce complications associated with standard glaucoma surgeries. MIGS involves the implantation of microscopic-sized equipment into the eye. In June 2012, the Food and Drug Administration (FDA) approved the first MIGS device.
Compared to traditional glaucoma surgeries, MIGS is associated with fewer complications, and patients tend to experience quicker recovery times. Although less risky, MIGS is not as effective in lowering eye pressure, and thus is not appropriate for patients suffering from advanced glaucoma. The long-term safety and efficacy of MIGS devices has not yet been determined.
As these procedures continue to advance, a team of researchers across various institutions, including Dr. Cui, recognized the significance of incorporating patient input into the evaluation of MIGS devices.
Patient-reported outcomes (PRO) measures serve to reassure physicians that their understanding of the benefits and drawbacks associated with an ophthalmic procedure reflects the perspectives of their patients. PRO measures help to ensure that ophthalmologists make treatment decisions that suit the individual needs of their patients.
Currently, measures exist that assess the well-being of those living with chronic eye conditions, including glaucoma. However, these assessments do not directly evaluate the impact of MIGS devices.
In response, Dr. Cui and collaborators from the U.S. Food and Drug Administration (FDA), the FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSI) based at Johns Hopkins University and UCSF-Stanford, and the American Glaucoma Society created a PRO questionnaire targeted towards glaucoma patients who are eligible to receive MIGS.
To develop this survey, researchers first elicited input from both patients and ophthalmologists by conducting in-person interviews. Patients were asked about the impact of glaucoma on their livelihoods, as well as their understanding of and concern for available treatment options. Patients also answered questions from the National Institutes of Health (NIH) Toolbox Vision-Targeted Health-related Quality-of-Life Survey, which assessed six domains of vision-related functioning and well-being using a standardized metric. The physicians were also asked questions, relaying their experiences treating glaucoma patients.
Researchers then drafted questions based on input from patients and recommendations from glaucoma specialists. This set of draft questionnaires was reviewed with a new group of patients to ensure it was clear and comprehensible.
The revised questionnaire, called the Glaucoma Outcomes Survey (GOS), consists of 52 items. The GOS includes questions that assess glaucoma patients’ functional limitations, psychosocial issues, vision-related symptoms, aesthetics, demographic characteristics, self-perceived disease severity, and change in quality of life related to glaucoma and functioning.
“The main purpose of this tool is to properly assess patients’ preferences and concerns, and incorporate that data into surgical planning for MIGS and selecting the appropriate glaucoma surgery for these patients,” said Dr. Cui. “This is increasingly important as more and more MIGS devices become available, and both physicians and patients are faced with a choice regarding which surgeries to perform.”
Next, the researchers plan to conduct field testing, a process that involves administering the GOS to patients with mild and moderate glaucoma who are candidates for MIGS. Study participants will be evaluated before and after receiving MIGS to quantify the utility of GOS as a clinical and research tool. The team is now in the process of eliciting volunteers by selecting academic and private clinical sites.
“We are currently in the planning stages of field testing, which will be done using online administration,” explained Dr. Cui. “The outpouring of interest in serving as a testing site has been amazing, and we are looking forward to collaborating with clinicians and researchers from across the country.”
Data collected from field testing will be used to assess the validity and reliability of the GOS. The final survey will be made available to researchers working to improve glaucoma surgical interventions. The survey can also be incorporated as a part of clinical care to illuminate patient concerns and facilitate decision-making in glaucoma treatment.