Evaluating Pilocarpine 1% Eye Drops in Presbyopia: A Triple-Blinded Randomized Trial

Presbyopia is an age-related condition that affects near vision and daily activities. Although several correction methods are available, each has certain limitations, leading to interest in pharmacologic alternatives such as pilocarpine eye drops. This study evaluates the safety and clinical effectiveness of 1% pilocarpine eye drops, as data on its use remain limited.

A triple-blinded clinical trial was conducted in 2024 in Yazd, Iran, enrolling 60 presbyopic patients aged 40-60 years. The study was approved by the Iranian Registry of Clinical Trials. Participants received either 1% pilocarpine eye drops or a placebo daily for 30 days. Their visual acuity-both near and distance-was assessed under mesopic conditions at six intervals. Throughout the trial, any side effects and treatment satisfaction were monitored. Statistical analysis was performed, considering results significant if p < 0.05.

In this study, the treatment group demonstrated a significant improvement in uncorrected near visual acuity (UNVA) at all follow-ups compared to the placebo group, peaking 1 hour after treatment (p ≤ 0.001). Although a significant change in uncorrected distance visual acuity (UDVA) from baseline was observed within the treatment group, no significant between-group difference in UDVA was found at the 30-day follow-up. Overall, patient satisfaction was significantly higher in those receiving pilocarpine (p ≤ 0.001).

This study supports previous research by showing improvements in UNVA, a quick onset of effects, and an acceptable safety profile. However, there was a slight worsening in UDVA; this may be due to higher initial measurements or temporary effects. Unlike many past trials, this study utilizes a rigorous triple-blinded design and measures effects at six different times, giving a thorough look at both the onset and duration of effects.

A 1% pilocarpine treatment has been found to significantly improve near vision in presbyopic patients, with minimal side effects and high patient satisfaction. Trial Registration: Iranian Registry of Clinical Trials (IRCT): IRCT20240325061363N1.