Cataract Clinical Trial
Official title:
A Clinical Trial to Evaluate the Safety and Effectiveness of Model SC9 Silicone IOL for the Visual Correction of Aphakia Secondary to the Removal of a Cataractous Lens in Adult Patients With or Without Presbyopia
To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb). Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects). Subjects will be followed for 36 Months. ;
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