Purpose This study aimed to evaluate the efficacy and safety of pilocarpine 1.25% eye drops for improving near vision acuity in presbyopic individuals.

Design Non-randomized prospective interventional trial

Methods This single-arm prospective interventional trial includes fifty presbyopic individuals aged between 40 to 55, administrated pilocarpine 1.25% eye-drops daily once (9 am, Hour 0) for one month. Visual parameters, including distance corrected near visual acuity (DCNVA), near add power, amplitude of accommodation (AoA), and depth of focus (DoF) along with ocular biometric parameters were assessed at baseline and after one month at hour 3 (12 noon) and hour 6 (3 p.m.). Adverse effects were monitored.

Results After one month of pilocarpine treatment, a significant improvement was observed in DCNVA (0.64±0.2 to 0.26±0.11, P:<0.001) along with a decrease in near add power (1.43±0.43 D to 0.42±0.22 D, P:<0.001). The AoA increased (3.23±0.74D to 3.92±0.93D, P:0.005), and DoF widened (0.72±0.18D to 0.81±0.26D, P:0.038). No change in ocular biometry parameters was observed. The change in DCNVA showed strong positive correlations with change in near add (r: 0.84, P:<0.001) and AoA (r: 0.66, P:0.04). Adverse effects were mild and did not lead to discontinuation.

Conclusion Pilocarpine 1.25% eye drops demonstrated statistically significant improvements in DCNVA, near add, AoA, and DoF after one month of treatment. Pilocarpine 1.25% eye drops shown increase in the amplitude of accommodation and depth of focus; without any significant change in ocular biometry parameters. The use of pilocarpine 1.25% eye drops can be an alternative intervention for enhancing near vision acuity of presbyopic subjects.

The authors have declared no competing interest.

CTRI: REF/2022/07/056632

This study did not receive any funding.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study received ethical approval from the AIIMS Institute Ethics Committee [Ref. No.: IEC-623/15.07.2022].

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