Article

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

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.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) The Residency Report: Study provides new insights into USH2A target end points
Lisa Nijm, MD, says preoperative osmolarity testing can manage patient expectations and improve surgical results at the 2025 ASCRS annual meeting
At the 2025 ASCRS Annual Meeting, Weijie Violet Lin, MD, ABO, shares highlights from a 5-year review of cross-linking complications
Maanasa Indaram, MD, is the medical director of the pediatric ophthalmology and adult strabismus division at University of California San Francisco, and spoke about corneal crosslinking (CXL) at the 2025 ASCRS annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Taylor Strange, DO, assesses early visual outcomes with femto-created arcuate incisions in premium IOL cases
(Image credit: Ophthalmology Times) ASCRS 2025: Neda Shamie, MD, shares her early clinical experience with the Unity VCS system
Patricia Buehler, MD, MPH, founder and CEO of Osheru, talks about the Ziplyft device for noninvasive blepharoplasty at the 2025 American Society of Cataract and Refractive Surgeons (ASCRS) annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Bonnie An Henderson, MD, on leveraging artificial intelligence in cataract refractive surgery
(Image credit: Ophthalmology Times) ASCRS 2025: Gregory Moloney, FRANZO, FRCSC, on rotational stability
Sheng Lim, MD, FRCOphth, discusses the CONCEPT study, which compared standalone cataract surgery to cataract surgery with ECP, at the 2025 ASCRS Annual Meeting.
© 2025 MJH Life Sciences

All rights reserved.