Chloroprocaine 3% Gel as a Novel Ocular Topical Anesthetic: Results from a Multicenter, Randomized Clinical Trial in Patients Undergoing Cataract Surgery.

Purpose: To compare the efficacy and safety of a novel ophthalmic anesthetic, chloroprocaine 3% gel to tetracaine 0.5% eye drops in patients undergoing cataract surgery with phacoemulsification. Methods: This was a prospective, randomized, multicenter, active-controlled, masked-observer, parallel group competitive equivalence study. The study comprised 338 patients having routine cataract extraction by clear corneal phacoemulsification, randomized to receive 3 drops of chloroprocaine gel (n = 166) or tetracaine eye drops (n = 172) before surgery. The primary objective of the study was to assess the equivalence of chloroprocaine gel to tetracaine eye drops as proportion of patients with successful ocular surface anesthesia, without any supplementation just before intraocular lens implantation. Safety measurements were pain, irritation, burning, stinging, photophobia, and foreign body sensation, graded by the patient and objective ocular signs. Results: Equivalence was demonstrated, with a somewhat higher success rate of chloroprocaine gel: 152/166 (92.0%) chloroprocaine versus 153/172 (90.5%) tetracaine patients achieved ocular surface anesthesia with no supplementation. Difference in proportions was 1.5% confidence interval [95% CI: (-3.6 to 6.6)] and 90% CI fell within (-10 to 10). Mean onset of anesthesia was 1.35 ± 0.87 min for chloroprocaine and 1.57 ± 1.85 for tetracaine (P = 0.083). Mean duration of anesthesia was 21.57 ± 12.26 min for chloroprocaine and 22.04 ± 12.58 for tetracaine (P = 0.574). No treatment emergent adverse events related to chloroprocaine were reported and no relevant findings related to local tolerance or vital signs were observed in both arms. Conclusions: Results obtained from the present cataract study demonstrated that chloroprocaine 3% ophthalmic gel is safe and effective, representing a valid alternative in ocular topical anesthesia. Clinical Trial Registration number: NCT04685538.

Results of pars plana vitrectomy for primary rhegmatogenous retinal detachment with PVR grades A and B in high-myopic eyes.

PURPOSE: To evaluate the results of pars plana vitrectomy (PPV) without adjuvant buckling procedures for the primary rhegmatogenous retinal detachment (RRD) with PVR grades A and B in high-myopic eyes. METHODS: A retrospective review included 291 eyes treated for primary RRD from 2008 to 2016. The single surgery success rate (SSSR), the total number of surgeries, outcomes and complications were analysed between group of 67 eyes with high axial myopia (group A) and group of 224 eyes without high myopia (group B). RESULTS: The mean follow-up was 30.6 ± 22.8 months. The SSSR in group A was 82.1% and in group B was 86.2% (p > 0.05). The final reattachment rate and number of required surgeries were in group A 96.3% (3.1 surgeries) and in group B 96.0% (2.8 surgeries). The initial BCVA improved in group A from 1.58 to 0.58 LogMAR at year 3; and in group B from 1.21 to 0.34 LogMAR. In match-pair analysis of macula-off RRD, no significant difference of the CRT between groups A and B was observed within 3 years of follow-up. CONCLUSION: The anatomical success of primary PPV for RRD did not differ between high-myopic and non-high-myopic eyes in PVR grades A and B. However, functional results of high-myopic eyes are worse compared to eyes without high axial myopia.