Lenstec receives FDA clearance to begin Softec HD IOL trial

Lenstec Inc. announced that the FDA has granted the company an Investigational Device Exemption (IDE) to begin a clinical trial of the Softec HD posterior chamber IOL.

Already approved for use throughout the European Union, the Softec HD is an aberration controlled bi-aspheric IOL designed to replace the human crystalline lens following cataract removal in patients 21 years of age and older. The lens joins Lenstec's expanding Precision Series line of monofocal and accommodating IOLs.

The new U.S. clinical trial will be based on implants performed on 300 eyes. Patient enrollment will begin this month at leading vision surgery centers nationwide.

The Softec HD is inserted through a 2.5- to 3-mm clear corneal incision using standard posterior chamber IOL insertion techniques. Based on the company's proprietary manufacturing technology, Premium Series lenses are designed to improve predictability in cataract surgery by reducing the variability (i.e., tolerance or margin of error) inherent in any manufactured lens.

The lens configuration was developed to reduce variability up to 300% compared with cataract replacement lenses manufactured in accordance with ISO standards. Variability is measured as the difference between a lens' labeled prescription and its actual power. The Softec HD is available with a tolerance of just 0.125 D, and in highly precise 0.25-D increments (from +18 to +25).

For more information, visit Lenstec at Booth 3638.