Comparative Clinical Outcomes of a 1.0% Versus 1.4% Sodium Hyaluronate OVD in Cataract Surgery: A Prospective Study.

INTRODUCTION

Maintaining anterior chamber space and protecting the endothelial layer during surgery is the primary role of ophthalmic viscosurgical devices (OVD), which have made them an integral part of the surgery for decades now. This study evaluated sodium hyaluronate-based OVDs BIO-HYALUR (1%) and Protectalon 1.4% in terms of their performance and safety during cataract surgery.

METHODS

This was a prospective, comparative, randomized clinical study involving patients undergoing cataract surgery. The primary endpoint was the incidence of intraocular pressure (IOP) rise > 30 mmHg; other clinical parameters including visual acuity, endothelial cell density (ECD) and morphology, corneal thickness, intraocular inflammation, and intraoperative parameters (phacoemulsification metrics, space maintenance, and surgeon performance rating) were also compared. Postoperative evaluations were conducted at 8 ± 2 h, 24 ± 4 h, 7 ± 2 days, 30 ± 7 days, and 90 ± 14 days.

RESULTS

The study included 140 patients (70 in each group) with a mean age of 63.8 ± 7.09 years and 63.4 ± 8.81 years for the BIO-HYALUR group and the Protectalon group, respectively. No patient in either of the groups showed an incident of IOP > 30 mmHg during the study period. ECD showed no clinically meaningful loss postoperatively in either of the groups. Intraocular inflammation was completely resolved by 7 ± 2 days, and lens and corneal clarity was achieved by 24 ± 4 h in both groups. No statistically significant difference was observed between the two groups for visual acuity and corneal thickness. Full chambered space maintenance was achieved in all cases (100%). Ease of use was rated as "excellent" in the vast majority of cases in both groups. No adverse events or intraoperative complications were observed during the study.

CONCLUSION

BIO-HYALUR and Protectalon 1.4% are safe and reliable OVDs in terms of intra- and postoperative parameters, and both OVDs are suitable for cataract surgery.

TRIAL REGISTRATION: CTRI/2023/03/050365.