Abstract

This study aimed to assess the efficacy and safety of fluoxetine on visual acuity in patients ≥10 years versus placebo, both combined with standard amblyopia treatment. This study was a systematic review and meta-analysis of randomized controlled trials (RCTs). All RCTs with patients ≥10 years with amblyopia treated with either fluoxetine or placebo plus standard amblyopia treatment were included. The primary outcome was the change in visual acuity measured by the logarithm of the minimum angle of resolution (logMAR). Secondary outcomes included contrast sensitivity, visual evoked potential (VEP) parameters, stereopsis, and treatment-related adverse events (AEs). This review included three RCTs with 132 patients. Meta-analysis of two of the included studies showed significant improvement of visual acuity with fluoxetine in comparison to placebo, with a mean difference of 0.12 (95% CI: 0.07 to 0.17, p-value = 0.001). No evidence of heterogeneity was found (I² = 0%). Another study not included in the meta-analysis showed a similar improvement in visual acuity in both groups. Other outcomes (stereopsis, contrast sensitivity, and VEP parameters) showed variable
results between studies. Another meta-analysis was conducted from two trials to assess the incidence of AEs in both the fluoxetine and placebo groups and showed no statistical significance. This study provided a basis for considering the use of fluoxetine as an adjunct therapy to standard amblyopia treatment in older patients. While this review showed promising results, limitations like short follow-up periods, lack of standardization, and small sample size of the included trials should be addressed in future research.

Key words: Amblyopia, fluoxetine, neuroplasticity, occlusion therapy, visual acuity, systematic review.