A Systematic Review and Meta-Analysis on the Efficacy and Safety of Topical Pilocarpine 1.25% in Presbyopia Treatment.

Abstract

Purpose: To do a qualitative and quantitative assessment of the existing literature on the effectiveness and safety of pilocarpine 1.25% eye drops in presbyopia management.

Methods: Relevant articles were extracted from the online database using keywords - "pilocarpine and presbyopia", "AGN-190584 and presbyopia", and "Vuity and presbyopia". The primary outcome measure considered was an improvement in distance-corrected near visual acuity (DCNVA) and secondary outcome measures were improvement in distance-corrected intermediate visual acuity (DCIVA) and adverse events (AEs). Risk of bias (ROB) assessment was done using the ROB2 tool and R software was used for quantitative analysis.

Results: The 3 included randomized control trials (RCTs) had a total of 980 participants between 40-55 years of age. They were randomized into 2 groups - 489 in the pilocarpine group and 491 in the vehicle group. In the pilocarpine group, 1.25% of pilocarpine was used either once (in the Gemini 1 and 2 trials) or twice daily (Virgo trial). A significantly higher proportion of patients reported improvement of DCIVA and gain of ≥ 3 lines in binocular DCNVA in the pilocarpine group than the vehicle group (P < 0.01). Headache was the most commonly reported AE (13.49% of participants). Three case reports published on pilocarpine use for presbyopia management have reported vitreomacular traction in 1 and retinal detachment in 5 eyes.

Conclusions: The available evidence documents significant improvement in near and intermediate vision in presbyopia participants with pilocarpine 1.25% drop. However, more RCTs, involving a wider age group, larger refractive error, longer follow-up, and clinical testing in a real-world scenario are required to conclusively prove its role in presbyopia management.