Objective <p>To compare the efficacy and safety of 0.50% and 0.75% pilocarpine ophthalmic solutions for treating presbyopia.</p> Methods <p>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).</p> Results <p>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, <i>p</i> = 0.02). After 2 weeks, the gain in photopic DCNVA was 0.18 logMAR for both concentrations (<i>p</i> = 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 (<i>p</i> = 0.25); photopic DCIVA, 0.14 and 0.09 logMAR (<i>p</i> = 0.02); mesopic DCIVA, 0.12 and 0.10 logMAR (<i>p</i> = 0.18).</p> Conclusion <p>Both 0.50% and 0.75% pilocarpine improved visual performance in presbyopia significantly, suggesting it is a promising treatment option.</p> Clinical trial registration <p>Chinese Clinical Trial Registry (ChiCTR), 2023/3/2, No.ChiCTR2300068971.</p>

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

  • Dan Fu,
  • Tian Han,
  • Qiyu Wang,
  • Jingbin Geng,
  • Shulong Gu,
  • Yuanjie Ji,
  • Taomin Huang,
  • Xingtao Zhou,
  • Ye Xu

摘要

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.