Introduction
The Device Protocol for ILS241-P002 is a postmarket interventional confirmatory clinical trial comparing the Clareon Toric and Eyhance Toric intraocular lenses. The study aims to evaluate the safety and effectiveness of these devices.
The Clareon Toric Aspheric Hydrophobic Acrylic IOL (Models SY6OWF, CNWOT3, CNWOT4, CNWOTS, CNWOT6) is the test product in this study.
Study Objectives
The primary objective is to compare the safety and effectiveness of the Clareon Toric IOL to the Eyhance Toric IOL. The secondary objective is to evaluate the visual acuity and overall performance of the test product.
The study will assess the risks and benefits of the investigational product and conduct evaluations on subjects who receive the implant.
Manual:
Download: Device Protocol for ILS241-P002: Clareon Toric vs Eyhance Toric
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