New IOL designed to reduce variability

January 1, 2007

St. Petersburg, FL-Lenstec Inc. says the FDA has granted it an investigational device exemption to begin a clinical trial of the Softec HD posterior chamber IOL.

St. Petersburg, FL-Lenstec Inc. says the FDA has granted it an investigational device exemption to begin a clinical trial of the Softec HD posterior chamber IOL.

The lens is an aberration-controlled bi-aspheric IOL designed to replace the crystalline lens following cataract removal. The trial will be based on implants performed on 300 eyes. Enrollment began in November.

The lens is inserted through a 2.5- to 3- mm clear corneal incision using standard posterior chamber IOL insertion techniques. The lens is designed to reduce variability up to 300%, according to the company. Variability is measured as the difference between a lens' labeled prescription and its actual power.