FDA study demonstrates safety and efficacy of novel viscous-dispersive OVD

September 20, 2004

Paris

Paris—A novel viscous-dispersive ophthalmic viscosurgical device (OVD) (DisCoVisc, Alcon Laboratories) offers excellent endothelial protection during uncomplicated cataract surgery and IOL implantation, according to the results of the FDA study presented by Satish Modi, MD, of New York.

The nine-center trial had a randomized, parallel group design and compared DisCoVisc with Healon (Advanced Medical Optics) in 249 patients undergoing cataract removal by phacoemulsification. Participating surgeons represented a mix of cohesive and dispersive OVD users, and patients received no prophylactic IOP-reducing medication.

The observers were masked for the primary endpoint evaluations that consisted of analyses of 1) proportions of patients experiencing IOP spikes ≥30 mm Hg at 6 hours, 24 hours, and 7 days after surgery and 2) changes in endothelial cell density from baseline to the exit visit at 90 days.

There were no significant differences between the two study groups in any of those assessments, although there were some numeric differences noticed favoring DisCoVisc over Healon in the proportion of eyes with IOP ≥30 mm Hg at Day 7 (0% versus 0.9%, respectively) and in the mean endothelial cell density change at 90 days (–6.4% versus –8.8%).

Rates of patients with achieving best-corrected visual acuity (BCVA) at 20/25 or better were slightly higher in the DisCoVisc group at Days 1, 30, and 90, but the difference compared with the Healon group was not significant. There were also no statistically significant differences between groups in the presence of aqueous flare, aqueous cells, or corneal edema.

Adverse events were generally similar between groups, although there were five cases of cystoid macular edema in the Healon group and none in the DisCoVisc group.

"DisCoVisc was exceedingly clear, allowed for easy capsulorhexis, provided good endothelial cell protection even with my use of a high flow technique, and was quite easy to remove after IOL implantation," Dr. Modi said.