One eye at a time: feasibility of unilateral 0.5% pilocarpine therapy in presbyopia management
DOI:
https://doi.org/10.18203/2349-3259.ijct20262503Keywords:
Presbyopia, Pilocarpine, Miosis, Near vision, Unilateral administration, Binocular vision, Visual acuity, Pharmacological managementAbstract
Background: The objective of the study was to evaluate the feasibility, efficacy, and patient tolerance of unilateral instillation of 0.5% pilocarpine for near vision improvement in presbyopic individuals.
Methods: This prospective interventional study included 130 eyes of 65 presbyopic individuals. A single drop of 0.5% pilocarpine was instilled in one eye of each participant once daily. Distance corrected near visual acuity was assessed uniocularly and binocularly on the 7th and 15th day following initiation of treatment. Subjective improvement in near vision was recorded using patient feedback on comfort and functional near tasks. Binocular vision, stereopsis, and patient- reported outcomes regarding reading comfort, glare, headache, and overall satisfaction were documented at each visit. After completion of 15 days, the same protocol was repeated in the fellow eye of the patient, following a unilateral sequential treatment approach. Statistical analysis was performed using paired t-test and Wilcoxon signed-rank test, as appropriate.
Results: The results demonstrated a clear and progressive improvement in near visual acuity over the two-week period with unilateral administration of 0.5% pilocarpine. Subjective assessment revealed improved reading ease and reduced dependance on near correction in the majority of participants. The treatment was well tolerated. Reported ocular side effects were mild and transient, including brow ache and mild dimming of vision, with no serious adverse effects recorded.
Conclusions: Unilateral administration of 0.5% pilocarpine is an effective and safe strategy for presbyopia management, providing meaningful binocular visual function. Sequential unilateral treatment may offer a practical, patient-friendly non-surgical option for presbyopia management.
References
Glasser A, Kaufman PL. The mechanism of accommodation in primates. Ophthalmology. 1999;106(5):863-72.
Duane A. Normal values of accommodation. Am J Ophthalmol. 1912;49:842-50.
Atchinson DA. Accommodation and presbyopia. Ophthalmic Physiol Opt. 1995;15(4):255-72.
Glasser A, Campbell MC. Presbyopia and the optical changes in the human crystalline lens with age. Vision Res. 1998;38(2):209-29.
Patel I, West SK. Presbyopia: prevalence, impact, and interventions. Community Eye Health. 2007;20:40-1.
Holden BA, Fricke TR, Ho SM, Wong R, Schlenther G, Cronjé S, et al. Global vision impairment due to uncorrected presbyopia. Arch Ophthalmol. 2008;126(12):1731-9.
Rich W, Reilly MA. A Review of Lens Biomechanical Contributions to Presbyopia. Curr Eye Res. 2023;48(2):182-194.
Knaus KR, Hipsley A, Blemker SS. A new look at an old problem: 3D modelling of accommodation reveals how age-related biomechanical changes contribute to dysfunction in presbyopia. Biomech Model Mechanobiol. 2024;23(1):193-205.
Ayaki M, Hanyuda A, Negishi K. Presbyopia and associated factors specific to age groups. Clin Exp Optom. 2025;12:1-6.
Zuo H, Cheng H, Lin M, Gao X, Xiang Y, Zhang T, et al. The effect of aging on the ciliary muscle and its potential relationship with presbyopia:a literature review. Peer J. 2024:12:e18437.
Cheng C. Tissue, cellular, and molecular level determinants for eye lens stiffness and elasticity. Front Ophthalmol. 2024;4:1456474.
Rich W, Reilly MA. A Review of Lens Biomechanical Contributions to Presbyopia. Curr Eye Res. 2023;48(2):182-94.
Wolffsohn JS, Davies LN. Presbyopia: Effectiveness of correction strategies. Prog Retin Eye Res. 2019;68:124-43.
Schachar RA. Cause and treatment of presbyopia with a method for increasing the amplitude of accommodation. Ann Ophthalmol. 1992;24(12):445-7.
Papadopoulos PA, Papadopoulos AP. Current management of presbyopia. Middle East Afr J Ophthalmol. 2014;21(1):10-7.
Wolffsohn JS, Davis LN. Presbyopia: Effectiveness of correction strategies. Prog Retin Eye Res. 2019;68:124-43.
Kohnen T, Biller ML, Lwowski C, Bohm M, Kaiser KP. Treatments for Presbyopia. Dtsch Arztebl Int. 2025;122(18):501-7.
Lam D, Nagra M, Michaud L, Obinwanne CJ, Orgill M, Koschmeder J, et al. Optical interventions for presbyopia. Cochrane Database Syst Rev. 2025;6(6):CD016285.
Wolffsohn JS, Davies LN, Sheppard AL. New insights in presbyopia: impact of correction strategies. BMJ Open Ophthalmol. 2023;8:e001122.
Katz JA, Karpecki PM, Dorca A, Chayet A, Koch DD, Flack AJ, et al. Presbyopia - A Review of Current Treatment Options and Emerging Therapies. Clin Ophthalmol. 2021;15:2167-78.
Haghpanah N, Alany R. Pharmacological treatment of presbyopia: A systematic review. Eur J Transl Myol. 2022;32:10781.
De Gracia P, Pucker AD. Pharmacological Modulation of Pupil Size in Presbyopia: Optical Modeling and Clinical Implications. J Clin Med. 2025;14:6040.
Grzybowski A, Kapitonovaite L, Zemaitiene R. An updated systematic review of pharmacological treatments for presbyopia. Adv Ophthalmol Pract Res. 2024;4:220-5.
Mousavi SA, Rajavi Z, Sabbaghi H, Hosseini SM, Kheiri B, Sheibani M, et al. Pharmacological Treatment of Presbyopia Using Pilocarpine 1.25% Eye Drops. J Ophthalmic Vis Res. 2024;19:468-75.
Saxena R, Gupta V, Velpandian T, Sharma P, Menon V, Dada T, et al. Pilocarpine 1.25% efficacy for management of uncorrected presbyopia (PILE-UP study). Indian J Ophthalmol. 2025;73:1486-90.
Singh P, Garasiya T, Ajila V, Sengupta S, Datta A, Nivean M. Efficacy and safety of pilocarpine hydrochloride ophthalmic solution USP 1.25% w/v versus placebo ophthalmic solution for the treatment of presbyopia - A multicentric clinical trial. Indian J Ophthalmol. 2025;73:1251-7.
Lima GN, Amaral DC, Ivanov YA, Costa VP, Ventura CV, Moraes HV Jr, et al. Short-Term Efficacy and Safety of Pilocarpine Ophthalmic Solution for Presbyopia: A Systematic Review and Meta-Analysis. Am J Ophthalmol. 2025;280:298-307.
Waring GO 4th, Price FW Jr, Wirta D, Robinson M, Moshirfar M, Liu H, et al. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022;140:363-71.
Holland E, Karpecki P, Fingeret M, Devries D, Sharma A, Hovanesian J, et al. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized Clinical Trials. Clin Ther. 2024;46:104-13.
Kannarr S, El-Harazi SM, Moshirfar M, Lievens CW, Lindstrom RL, Berdy GJ, et al. Safety and Efficacy of Twice-Daily Pilocarpine HCl in Presbyopia: The VIRGO Phase 3, Randomized, Double-Masked, Controlled Study. Am J Ophthalmol. 2023;253:189-200.
Waring GO 4th, Brujic M, McGee S, Liu H, Batoosingh AL, Robinson M. Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. Clin Exp Optom. 2024;107:665-72.
Renna A, Vejarano LF, De la Cruz E, Alió JL. Pharmacological treatment of presbyopia by novel binocularly instilled eye drops: a pilot study. Ophthalmol Ther. 2016;5:63-73.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191-4.
Khokhar S. Pearls on choosing presbyopia correction IOLs. Indian J Ophthalmol. 2024;72:1233-5.
Chaurasiya SK, Agarwal P. Comments on "the effect of 2% pilocarpine on depth of field in different time intervals among presbyopic subjects". Indian J Ophthalmol. 2025;73:S350-1.
Lievens CW, Hom MM, McLaurin EB, Robinson M, Liu H, Batoosingh AL, et al. Pilocarpine HCl 1.25% in post-LASIK presbyopia: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2). J Cataract Refract Surg. 2024;50:57-63.
Abdelkader A, Kaufman HE. Clinical outcomes of combined versus separate carbachol and brimonidine drops in correcting presbyopia. Eye Vis (Lond). 2016;3:31.
Price FW Jr, Hom M, Moshirfar M, Berdy GJ, Lievens CW, Liu H, et al. Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia: Two Randomized Phase 2 Studies. Ophthalmol Sci. 2021;1:100065.