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.

Efficacy of vector thermal pulsation treatment in reducing postcataract surgery dry eye disease in patients affected by meibomian gland dysfunction.

PURPOSE: To evaluate the effect of a single LipiFlow vector thermal pulsation treatment performed before cataract surgery in reducing signs and symptoms of postoperative dry eye disease (DED) in patients with mild-moderate meibomian gland dysfunction (MGD). SETTING: Eye Clinic, Careggi Hospital, University of Florence, Florence, Italy. DESIGN: Prospective unmasked randomized controlled clinical trial. METHODS: This study included patients affected by age-related cataract and mild-moderate MGD, who were randomized into 2 groups: (1) a single LipiFlow treatment performed at 5 preoperative weeks and (2) warm compresses and eyelid massages twice a day for 1 preoperative month (control group). Noninvasive break-up time (NI-BUT), Schirmer test, Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and MG functionality parameters were evaluated at visit 0 (5 preoperative weeks), visit 1 (1 preoperative week), and visit 2 (1 postoperative month). Confocal microscopy of the MG of lower eyelids was performed at visit 0 and visit 2. RESULTS: A total of 46 patients (46 eyes) were enrolled. In the LipiFlow group (n = 23), NI-BUT, SPEED questionnaire, and MG functionality parameters significantly improved at visit 1 ( P < .05) and visit 2 ( P < .05) compared with baseline and remained stable postoperatively. In the control group (n = 23), they did not significantly improve after treatment, while worsened postoperatively. Moreover, the changes in all parameters from baseline were significantly different between the 2 groups. Confocal microscopy imaging highlighted lower postoperative MG alterations in the LipiFlow group. CONCLUSIONS: A single preoperative LipiFlow treatment was effective in preventing postcataract surgery DED in patients with mild-moderate MGD. Postoperatively, treated patients displayed a better ocular surface status compared with warm compresses.