Surgeon acceptance and safety of a new ophthalmic viscosurgical device (OVD)
First Author: A.Gavin Sancho SPAIN
Co Author(s): C. Isanta J. Larrosa A. Langenbucher L. Daas B. Jackson P. Janakiraman
To evaluate the clinical acceptability of the bacterially-derived Healon PRO Ophthalmic Viscoelastic Device (OVD) when compared to the animal-derived Healon OVD under normal use conditions during cataract surgery.
Prospective, multicenter, comparative clinical trial conducted at sites across Europe assessed Healon PRO (test) and Healon (control) OVD. 73 and 70 eyes received test and control products respectively.
A total of 16 surgeons participated in the evaluation of clinical performance of Healon OVD on a 5-point scale via questionnaire. In addition, safety of both products were assessed at 1 day post-operative by measuring intraocular pressure (IOP) spikes equal to or higher than 30mmHg, mean change in IOP from baseline and serious and/or device-related adverse events.
The overall clinical performance was rated acceptable in more than 90% for both test and control products and met the non-inferiority margin of 15%. No statistically significant difference was observed for viscosity acceptability, endothelium adherence, anterior chamber maintenance, quantity of bubbles, tissue manipulation and ease of removal between OVD groups. Statistically significant improvement was observed with test OVD for transparency/visibility, ease of injectability and ease of IOL placement. No statistically significant difference was observed in IOP spikes and change in IOP from baseline between groups. Overall safety profile was similar between test and control OVD products.
The results of this clinical investigation demonstrate reasonable assurance of the overall acceptable clinical performance of the Healon PRO OVD, as well as its safety and effectiveness in intraocular surgery.
is employed by a for-profit company with an interest in the subject of the presentation