Oral fluoxetine in the management of amblyopic patients aged between 10 and 40 years old: a randomized clinical trial.

OBJECTIVE

The objective of this study is to assess the efficacy of oral fluoxetine therapy in improving the visual function of amblyopic patients aged between 10 and 40 years old.

METHODS

In this double-blinded, randomized, controlled trial (IRCT2016052428046N1; registered retrospectively), 40 eligible participants with anisometropic or mixed amblyopia were randomly assigned to either fluoxetine or placebo groups. Participants with anisometropia and logMAR best spectacle-corrected visual acuity (BSCVA) worse than 0.2 logMAR in the amblyopic eye or at least a two-line of difference in the BSCVA between the fellow eyes were included. Participants with significant ocular or systemic diseases were excluded. In both groups, the better eye of each patient was patched for 4-6 h a day during the study period. Participants in the treatment group were treated with oral fluoxetine for 3 months. Change in the Snellen BSCVA (after 3 months) was regarded as the primary outcome measure.

RESULTS

Data from 20 participants in the fluoxetine group and 15 participants from the placebo group were analyzed (aged 11-37 years). The magnitude of improvement in visual acuity (from baseline to 3 months after treatment) was significantly higher in the fluoxetine group (0.240 ± 0.068 logMAR; 2.4 line-gain) compared with the control group (0.120 ± 0.086 logMAR; 1.2 line-gain).

CONCLUSIONS

This study suggests beneficial effects of fluoxetine in the management of adult and adolescent amblyopia.