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Tecnis 1-piece acrylic IOL launched in the U.S.
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CHICAGO — Advanced Medical Optics announced the launch of a new acrylic monofocal IOL here at the American Society of Cataract and Refractive Surgery meeting.
The Tecnis 1-piece model ZCB00 received U.S. Food and Drug Administration (FDA) approval in October, and recently was granted new technology IOL status by the Centers for Medicare and Medicaid Services. The CMS designation provides for surgeons to be reimbursed an additional $50 per lens implanted in an ambulatory surgical center.
Donald R. Nixon, MD, presented his results from 17 patients out of an original group of 20 who were implanted with the hydrophobic lens after uncomplicated phacoemulsification, stating that his results are comparable to the FDA clinical trial of the lens, which included 123 patients. The follow up in Dr. Nixon's study ranged from 26 to 29 months. Three patients of the 20 were lost to follow up.
At the end of the study, he found that 100% of patients had 20/40 or better best corrected visual acuity. No cases required Nd:YAG laser capsulotomies, and the lens remained well-positioned and demonstrated "good lens capsular dynamics," he said.
He said the lens, with a 360° uninterrupted barrier edge, features a unique treatment design that helps reduce surface tackiness and ensures easy unfolding. The frosted edge design is geared to reduce glare, in addition to minimizing cell migration into the posterior capsule, Dr. Nixon said. In addition, the Tecnis IOL Tri-Fix design grants a three-point fixation for inreased stability, he said.
"This is a safe and effective lens ... it has the benefits of a one-piece design and an excellent track record," Dr. Nixon said.
In the FDA trial, 123 patients were implanted and followed for 2 years. The trial found at 1 year that 100% of all subjects achieved best corrected distance visual acuity of 20/40 or better, while 82.9% achieved best corrected distance visual acuity of 20/20 or better. Approximately 91% of subjects had 20/40 or better uncorrected visual acuity at distance, Dr. Nixon said. The 2-year results were similar, he said.