A Comparative Clinical Study of 0.50% Versus 0.75% Pilocarpine Eye Drops for Improving Visual Performance in Presbyopia.

OBJECTIVE

To compare the efficacy and safety of 0.50% and 0.75% pilocarpine ophthalmic solutions for treating presbyopia.

METHODS

In this prospective study, 22 presbyopic subjects (44 eyes) were assigned to use 0.50% or 0.75% pilocarpine bilaterally, once daily for 2 weeks. Primary outcomes included distance-corrected intermediate visual acuity (DCIVA) at 66 cm and distance-corrected near visual acuity (DCNVA) at 40 cm under photopic and mesopic conditions, pupil size, refractive error, intraocular pressure (IOP) and patient-reported adverse events. Assessments were conducted at baseline, day 1 (after 1 and 6 h) and week 2 (after 1 h).

RESULTS

No serious adverse events occurred. Neither formulation affected IOP or refractive error significantly. Pupil constriction was greater in the 0.75% group than the 0.50% group (2.8 ± 1.1 vs. 2.0 ± 0.8 mm, p = 0.02). After 2 weeks, the gain in photopic DCNVA was 0.18 logMAR for both concentrations (p = 0.70). The respective gain in visual acuity measures for the 0.75% and 0.50% groups was: mesopic DCNVA, 0.14 and 0.19 logMAR (p = 0.25); photopic DCIVA, 0.14 and 0.09 logMAR (p = 0.02); mesopic DCIVA, 0.12 and 0.10 logMAR (p = 0.18).

CONCLUSION

Both 0.50% and 0.75% pilocarpine improved visual performance in presbyopia significantly, suggesting it is a promising treatment option.

CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), 2023/3/2, No.ChiCTR2300068971.