Dose-Dependent Efficacy And Safety Of Pilocarpine-Diclofenac Eye Drops For Presbyopia: A Real-World Single-Center Study

To evaluate the dose-dependent efficacy and safety of pilocarpine-diclofenac eye drops at 1%, 2%, and 3% concentrations (Benozzi Method) for presbyopia management. This real-world study assessed both short-term (1-hour post-instillation) and long-term (up to 2 years) outcomes. The primary objective was to determine the extent of uncorrected near visual acuity (UNVA) improvement and assess the safety profile, particularly the incidence and severity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE).

A single-center, retrospective study was conducted at CIAP Centro de Investigación Avanzada de la Presbicia, Buenos Aires, Argentina, utilizing a structured electronic medical record system to ensure standardized patient evaluation and follow-up.

Patients diagnosed with presbyopia (Jaeger 3 equivalent 20/30 or worse) were treated with pilocarpine-diclofenac eye drops (1%, 2%, or 3%), administered twice daily. The primary outcome was the 3 lines or more improvement in UNVA (Jaeger notation), assessed 1 hour post-instillation and at 1- and 12-month follow-ups. Secondary outcomes included binocular uncorrected distance visual acuity (UDVA), intraocular pressure (IOP) changes, adverse events, and spectacle dependence reduction. Safety data were classified using CTCAE guidelines, and statistical significance was set at p < 0.05.

A total of 766 patients were analyzed (373 women, 393 men; mean age 55 years, range 37–77). UNVA improved significantly across all concentrations (p < 0.05), with a clear dose-response effect:

• 1% group: 99% of 148 patients achieved ≥2-line improvement (Jaeger 1).
• 2% group: 69% of 248 patients achieved ≥3-line improvement.
• 3% group: 84% of 370 patients achieved ≥3-line improvement.

The effect was sustained for up to 2 years, with a median duration of 434 days. No serious adverse events were reported over 167,000 participant-treatment days. The most common mild and transient events were temporary dim vision (32%), instillation irritation (3.7%), and headache (3.8%). All ocular adverse events were mild, and no patients discontinued treatment.

Pilocarpine-diclofenac eye drops provide rapid, dose-dependent near vision improvement, sustained over 2 years, with a favorable safety profile. The treatment was well-tolerated, with no serious adverse effects and 100% treatment adherence. These findings support its potential as a non-surgical alternative for presbyopia management treatment.