The objective of the paper is to summarize the progress of two projects started by the FDA to assess patient perspectives regarding MIGS devices for mild to moderate open-angle glaucoma (OAG). One project is a questionnaire and the other one is a patient preference study to identify which outcomes matter most to them.
Questionnaire. The first phase of the questionnaire development was a physician focus group followed by patient focus groups. The information obtained from those groups, in addition to a review of the literature, was used to draft the questionnaire items.
The following categories were identified by both physicians and patients: night driving, loss of depth perception, esthetics, light sensitivity, and reading difficulties. A list of concepts deemed relevant for incorporation in the questionnaire were revised based on the 25 cognitive interviews resulting in a 52-item questionnaire. This questionnaire will be administered in a future field test with 500 or more respondents to evaluate its reliability and validity.
Patient preference study. A preference survey was drafted using 13 outcomes that patients perceived as important based on 25 one-on-one interviews.
The most important outcomes identified by the participants were 'adequate IOP control' and 'drive a car during the day' which were consistent with the ones identified in the questionnaire. Participants also expressed that the ability to perform other vision-dependent activities and maintaining visual perceptions are more important than burden of treatment.
Many of the outcomes that participants deemed as most important to them are not currently being measured consistently in MIGS studies. However, we should strive to identify those surgical techniques that meet the real expectations and needs of the patients. For this reason, studies and questionnaires such as those reported in this paper are crucial to the development of patient-oriented medicine.