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FDA grants IDE to begin trial of new aberration-controlled IOL

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LAS VEGAS — The Food and Drug Administration has granted Lenstec Inc. an Investigational Device Exemption to begin a clinical trial of its Softec HD posterior chamber IOL, the company announced here at the American Academy of Ophthalmology meeting.

Softec HD is an aberration-controlled bi-aspheric IOL already approved in the European Union. The new U.S. clinical trial will involve 300 eyes, with enrollment expected to begin this month, according to a press release from Lenstec.

The Softec HD is based on the company's Precision Series line of monofocal and accommodating IOLs, which are designed to improve predictability by reducing the variability inherent in manufactured lenses. Variability is the difference between a lens' labeled prescription and its actual power. The Softec HD was developed to reduce variability up to 300% compared to IOLs manufactured in accordance with ISO standards and is available with a tolerance of 0.125 D in 0.25 D increments, according to the release.