Randomized Prospective Paired Eye Comparative Study of 2 Cohesive–Dispersive OVDs Versus OVDs in Cataract Surgery
Purpose
Purpose: The objective of this study is to establish safety when using Healon with Healon Endocoat in routine cataract surgery versus a commercially approved product (Duovisc: Provisc and Viscoat). More specifically, the ability of healon endocoat to protect the cornea and the effects of this OVD on postoperative intraocular pressure will be studied against Duovisc.
Methods
Methods: Randomized, prospective, paired eye, comparative evaluation of 55 patients, 110eyes at a single site. Corneal endothelial protection and intraocular pressure spikes will be evaluated between Healon/Healon Endocoat versus Duovisc. A paired t-test with a 0.05 one-sided significance level and a between eye standard deviation of 5 will have 80% power to detect a between eye difference in IOP of at least 2 mmHg postoperative IOP to assess side-effects of Healon with Healon Endocoat .
Results
Results: Enrollment on-going, results pending
Conclusion
Conclusion: Pending Results