Safety of an Intracameral Fixed Combination for Mydriasis and Intraocular Anaesthesia During Cataract Surgery

Abstract

Purpose

To compare the safety of a standardized, commercially available intracameral combination of mydriatics and anesthetic (ICMA) with a reference topical mydriatic regimen for cataract surgery.

Patients and Methods

The safety results from two international, randomized, controlled clinical studies were combined to compare ICMA at the beginning of cataract surgery (ICMA group) to the reference topical mydriatic regimen (reference group). Data were collected on ocular and systemic adverse events, corneal and anterior chamber examination, endothelial cell density, retinal thickness and visual acuity. Analysis was performed on a pooled safety set from both studies, preoperatively and up to 1 month postoperatively.

Results

342 patients received ICMA and 318 the reference topical regimen. Ocular adverse events were reported in 17.0% of patients in the ICMA group and 18.6% in the reference group. No difference was shown between groups in endothelial cell density (2208 ± 498 cells/mm² for ICMA group versus 2241 ± 513 cells/mm² for the reference group; p=0.547) and retinal thickness (change from baseline less than 50 µm in 94.7% versus 95.0% of patients, respectively) at 1 month postoperatively. At 1-day post-surgery, less patients in the ICMA group had moderate or severe (Grades 2 and 3) superficial punctate corneal staining (3.9% versus 7.0% for the reference group; p=0.064). Postoperatively, some ocular symptoms were also less frequently reported in the ICMA group. Best-corrected visual acuity increased in 96.0% of patients in the ICMA group and 95.8% in the reference group at 1 month.

Conclusion

ICMA injection at the beginning of cataract surgery was demonstrated to be safe and may also provide perioperative and postoperative advantages over the standard topical mydriatic regimen.

Keywords:

• cataract surgery
• intracameral mydriasis
• topical mydriasis
• safety
• tolerability

Data Sharing Statement

Since the data were collected from two clinical trials, these are not intended to be shared by the authors, and no other study-related documents will be made available.

Acknowledgments

This study was conceived and funded by Laboratoires Théa, Clermont Ferrand, France.

Disclosure

AB, BC, FC, and RM are consultants for Laboratoires Théa. BC reports personal fees from Thea consultant and clinical investigator, outside the submitted work; and Clinical investigator and consultant for: Hoya, Horus, J&J, B&L, Roche. The authors report no other conflicts of interest in this work.