Pilocarpine 1.25% efficacy for management of uncorrected presbyopia (PILE-UP study).

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: Prospective interventional single-arm clinical trial.

Methods: This single-arm prospective interventional trial includes 50 presbyopic individuals aged between 40 to 55, administered 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 pm). 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 ± 0.74 D to 3.92 ± 0.93 D, P: 0.005), and DoF widened (0.72 ± 0.18 D to 0.81 ± 0.26 D, 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 AoA and DoF; 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.