ClearViscTM (Bausch Surgical), a dispersive ophthalmic viscosurgical device (OVD), met its primary safety and efficacy endpoints and was demonstrated to be noninferior to Viscoat® (Alcon), according to findings presented at the American Academy of Ophthalmology (AAO) 2022 annual meeting, held in Chicago from September 30 to October 3.
Researchers conducted a study to assess the incidence of increase in intraocular pressure (IOP) and the loss of endothelial cell density (ECD) in patients who underwent cataract surgeries using the ClearVisc OVD, compared with patients whose surgeries used the Viscoat OVD.
Participants were enrolled and followed for 3 months. The researchers assessed safety by monitoring postoperative IOP spikes to 30 mm Hg or higher. Effectiveness was assessed by percent change in ECD before and after the operation.
The study found that ClearVics (n=182) and Viscoat (n=187) have equivalent safety and efficacy findings. The percent of patients in the study who experienced IOP elevations to 30 mm Hg or greater using the ClearVisc was 17.4%, while that elevation was seen in 20.3% of patients whose surgeries used Viscoat (P =.0002).
The percent of ECD loss from baseline was 8.7% in patients whose surgeries used ClearVisc, vs 6.8% for those who used Viscoat (P =.0032). Most eyes had clear corneas by 1 week (ClearVisc, 99.5%; Viscoat, 98.4%).
Disclosure: The study author declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of author’s disclosures.
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References:
Packer M. Safety and effectiveness of a new FDA-approved dispersive ophthalmic viscosurgical device. Poster presented at: The American Academy of Ophthalmology (AAO) 2022 annual meeting; September 30-October 3; Chicago. Abstract PO038