NEI/FDA conference to analyze functional vision outcomes from clinical trials of visual prostheses

The National Eye Institute (NEI) and Food and Drug Administration (FDA) are sponsoring a conference to determine how functional vision-related endpoints for clinical trials of visual prostheses will be analyzed and correlated with objective measures of visual acuity, visual fields and contrast sensitivity. These assessments may provide valuable information that will corroborate standard clinical test outcomes.

Today, functional vision outcomes — such as how patients perform orientation and mobility tasks and other daily living activities — are being incorporated more frequently into randomized clinical trials.

A growing body of evidence strongly suggests that functional vision data may provide a better understanding of what patients can actually do beyond the data obtained from visual acuity or visual field measurements. The FDA is already incorporating this type of clinical data into guidance for clinical trials of investigational visual prostheses.

Agenda highlights

‧ Differentiate between functional vision and visual function
‧ Provide an overview of guidance documents relevant to visual prostheses
‧ Identify critical elements in orientation and mobility assessments as they relate to retinal implants
‧ Identify critical elements of activities in daily living assessment necessary to establish effectiveness of retinal implants to improve visual function
‧ Interactive/open discussion with leaders in the field of vision rehabilitation and visual prostheses regarding next steps

This meeting, part of an NEI/FDA series of Endpoints Symposia, will explore the issues and challenges related to functional vision information in ophthalmology. Participants will also look at FDA guidelines for using functional vision outcomes and how they are incorporated for the investigation and labeling of medical devices and drugs.

Faculty will include authorities in vision rehabilitation, orientation and mobility, occupational therapy, ophthalmology and optometry. FDA representatives will present insights about how the FDA reviews and evaluates functional vision outcomes in support of product labeling for visual prostheses and drugs used for the treatment of retinal diseases.

The goal of this meeting is to obtain recommendations for measuring specific tasks of mobility and daily living activities as well as how they will be analyzed and correlated with objective measures of visual acuity and contrast sensitivity in the clinical trial.