Abstract
BACKGROUND: Presbyopia, an age-related condition characterized by the gradual loss of near vision accommodation, affects a substantial portion of the global population. While Pilocarpine has demonstrated effectiveness in managing presbyopia, there is increasing interest in exploring combination therapies to enhance treatment efficacy and tolerability. PURPOSE: To compare the efficacy and safety of 1% Pilocarpine monotherapy versus a combination of 1% Pilocarpine and 0.09% Bromfenac for the treatment of presbyopia over an 8-week period. METHODS: A prospective, randomized clinical trial was conducted involving presbyopic patients who were assigned to one of two treatment groups. Evaluations were performed to assess near visual acuity, accommodative function, patient satisfaction, safety, and compliance. RESULTS: Both treatment groups showed significant improvements in near vision function. At the 8-week mark, 44.1% of patients in the Pilocarpine-only group and 78.6% of those in the combination therapy group achieved N6 near vision. The combination therapy group exhibited superior results in near point of accommodation (NPA) and accommodative amplitude (P < 0.05). Patient satisfaction improved similarly in both groups. However, the combination therapy group reported fewer adverse events (1.8% vs. 11.9%, P < 0.05) and higher treatment compliance (96.4% vs. 64.4%, P < 0.001). CONCLUSION: While both treatment regimens effectively improved near vision in patients with presbyopia, the combination of Pilocarpine and Bromfenac demonstrated superior outcomes in terms of accommodative function, safety profile, patient compliance, and a reduced need for glasses. These results suggest that this combination therapy may offer a more effective pharmacological approach to the management of presbyopia.