An Investigation of Vitamin A Palmitate Supplementation in Patients withAMD and/or Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation

National Eye Institute

Investigators

Abstract

Objective: The objective of this study is to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with reticular pseudodrusen (RPD) and abnormal dark adaptation. Study Population: Ten participants will be initially accrued, however, up to twenty participants with RPD who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to receiving two months of study supplementation for a reason unrelated to an adverse reaction, an additional participant will be accrued. A maximum of ten additional participants may be accrued in order to obtain ten participants for the primary outcome analysis. Design: This is a pilot, uncontrolled, prospective, single center study to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with AMD and abnormal dark adaptation. Outcome Measures: The primary outcome is the measurement of dark adaptation parameters (thresholds and kinetics) by the following: dark adaptation times as measured by the AdaptDx comparing before and after vitamin A palmitate and dark adaptation parameters as measured by the Medmont comparing before and after vitamin A palmitate supplementation. The secondary outcomes are changes in low luminance visual acuity (LLVA) and changes in patient reported outcomes as measured by the low luminance questionnaire (LLQ).