Lipoic acid eye drops for treatment of presbyopia: A pilot randomized controlled clinical trial

Purpose: To evaluate the effectiveness of Lipoic acid eye drop for treatment of patients with presbyopia.Methods: In this pilot randomized, double-blind, placebo-controlled phase 2 study, a total of 30 emmetropic patients with presbyopia were assigned to receive lipoic acid eye drop (n=15) or placebo (n=15). Patients were instructed to use eye drops in each eye twice a day for 90 days. The outcome measures of the study were, uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), subjective amplitude of accommodation (both push-up and minus-lens methods) prior and 1,15,31,61 and 91 days post-administration. Results: The mean age of patients was 47.2 ±3.2 years (range, 42-53 years). UDVA for all patients was 20/20 in each eye and remained unchanged during the follow-up periods. The mean logMAR of binocular UNVA for intervention group improved after 15 days of using lipoic acid eye drops in comparison with placebo. The difference between two groups reached the highest level at the final follow-up (p=0.001). Three patients(20%) reported burning in intervention group. Conclusion: This pilot randomized controlled trial of 90 days of presbyopia treatment with lipoic acid eye drop, demonstrated improvement in near vision of presbyopic patients and no reduction for distance visual acuity was observed. Additional controlled trials with larger samples are needed to evaluate the full efficacy and side effect profile of lipoic acid eye drop for treatment of presbyopia.