Visual field and ocular safety during short-term vigabatrin treatment in cocaine abusers

Abstract

Purpose: To evaluate the ocular safety of short-term vigabatrin treatment of cocaine abuse.

Design: Multicenter, prospective, randomized, placebo-controlled, double-masked, parallel assignment study.

Methods: Cocaine addicts were randomized to receive vigabatrin 3000 mg/day, cumulative dose 218 g (n = 92), or placebo (n = 94) for 12 weeks. Subjects underwent examination of visual acuity (ETDRS) and peripheral visual field (PVF) by Humphrey Field Analyzer (HFA) 60-4 program before and after treatment. Reliable PVF tests (fixation loss, false positive, and false negative <33%) for 103 subjects were included for the analysis. The threshold visual sensitivity (TVS) was analyzed by points, rings and zones. Main outcome measures included visual acuity decrease by 15 letters and/or significant PVF alteration, defined as 5 or more visual field location points having greater than or equal to 15 dB reduction in TVS or decline (≥33% loss) in posttreatment TVS for 1 or more rings.

Results: Visual acuity decrease was detected in 1 eye of a subject receiving placebo and in none receiving vigabatrin. Posttreatment reduction in TVS more than 15 dB in 5 or more adjacent visual field location points combined with reduction in TVS greater than 33% in 1 or more of the rings was detected in 2 of 54 subjects (3.7%) from the vigabatrin group and in 1 of 49 subjects (2%) from the placebo group (P = .9, NS). None of the PVF changes were bilateral or concentric.

Conclusions: Short-term use of vigabatrin did not cause a decrease in visual acuity or significant peripheral visual field changes in cocaine abusers.

Trial registration: ClinicalTrials.gov NCT00611130.