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New toric IOL shows stability, safety and efficacy
LOS ANGELES — The new Bausch + Lomb enVista toric IOL met all safety and efficacy endpoints in a pivotal FDA trial, according to a presentation here.
“Premarket approval application to the FDA is underway,” Richard Hope, MD, said at the American Society of Cataract and Refractive Surgery meeting.
Richard Hope
The toric model uses the platform of the enVista IOL, already approved in 2012. It is made of glistening-free hydrophobic acrylic material with a toric optic in the posterior surface and axis markers on the edge. It received the European CE mark in 2012, but the FDA required another study.
The study was double-masked, partially randomized and partially controlled. Patients with a low amount of corneal cylinder, between 0.90 D and 1.30 D, were randomized to either the nontoric sphere model (80 subjects) or the 1.25 D toric model (80 subjects). The 40 patients with higher corneal cylinder, between 1.40 D and 2.40 D, were assigned to the same toric lens with 2.00 D or 2.5 D cylinder power. The follow-up was 6 months.
“With a toric lens, the first thing you want to know is if it is rotationally stable. The mean rotation was 1.10 degrees and 100% of the lenses rotated less than 5 degrees,” Hope said.
All three toric lenses significantly outperformed the nontoric lens for cylinder reduction and uncorrected distance vision.
“The EnVista toric is also a safe lens,” Hope said. “No serious adverse events or device-related event occurred, a few patients had mild CME, not persistent. No secondary intervention was performed.”– by Michela Cimberle
Reference:
Hope R. Results of a prospective, multicenter clinical trial to evaluate the safety and effectiveness of a new toric intraocular lens. Presented at: American Society of Cataract and Refractive Surgery annual meeting; May 5-9, 2017; Los Angeles.
Disclosure: Hope reports he is an employee of Bausch + Lomb.