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Ophtec CTR provided support in patients with weak zonules
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The Ophtec CTR safely provided capsular support during and after cataract surgery in patients with weak or partially broken zonules, according to a study.
Francis W. Price Jr., MD, and colleagues reported interim results in 224 subjects at nine sites nationwide who were implanted with 255 capsular tension rings (CTRs). The devices were implanted in patients who were found to have a weakened or partially broken ciliary zonule comprising less than 34% of the circumference of the lens capsule.
Two models of CTR were evaluated, one with an uncompressed diameter of 12 mm and one with an uncompressed diameter of 13 mm. Patients were examined preoperatively, intraoperatively and at day 1 and months 1, 3, 6 and 12 postop.
Immediately after surgery, all but three IOLs were centered. The prevalence of a decentered IOL was 1.7% at 3 months after surgery. At 6-month follow-up, the prevalence of decentration increased to 3.8%, but it dropped back to 2.3% by 12 months.
The primary complication was posterior capsular opacification, which the researchers said was not a result of the CTR implantation.
The Ophtec device was approved for marketing by the Food and Drug Administration last year. The device is marketed in North America by Advanced Medical Optics as the Stabileyes.
The study by Dr. Price and colleagues is published in the March issue of Ophthalmology.