Prospective Interventional Non-Comparative Non-Randomized Clinical Study of A Topical Synergic Compound to Mitigate Presbyopia Effects
Abstract Purpose To assess the safety and efficacy of a novel compound with low -dose pilocarpine, brimonidine and oxymetazoline (PBO) in the near vision of a group of healthy presbyopic individuals. Design Prospective, consecutive, noncomparative, nonrandomized interventional study. Subjects Twenty-six healthy presbyopic patients presented from August to September 2021 to our clinic and were willing to participate in the study. Methods PBO compound was instilled in both eyes to assess its effect in near vision one hour after instillation.Main Outcome Measures Under corrected near visual acuity using the Jaeger notation, under corrected and corrected distance visual acuity, photopic and scotopic pupil diameter was registered before and one hour after instillation of the compound. Results Baseline binocular Jaeger notation was 5.86 +/-1.39 SD range (3-9). One hour after drop instillation, binocular Jaeger was 2.53 +/ 1.71 SD range (1 – 6) (p ≤ 0.0001) Lines gained 3.30 +/-1.40 SD range (0 – 6). Mean photopic pupilar diameter was 3.69 mm +/- 0.67 SD range (2.5 – 5 mm). Mean scotopic pupilar diameter was 4.61 mm +/- 0.78 SD range (3 – 6 mm). The mean photopic pupilar diameter was 2.27 mm +/-052 SD (1.5 – 3) (p ≤ 0.000). Scotopic pupilar diameter was 2.63 mm +/-0.53 SD range (2 – 3) (p ≤ 0.000). One patient reported no improvement in near vision. (3.8%). One patient reported dim vision rated 5 in a VAS (1 –10) (3.8%). Conclusion Low-dose pilocarpine, brimonidine, and oxymetazoline showed efficacy, improving near-distance vision one hour after instillation in a group of presbyopic patients, and safety showed few and transient secondary effects.