VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

VisiOn Restoration With the FluidVisION AIOL

The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.

This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Key Inclusion Criteria:

• Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;
• Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D);
• Calculated IOL power within range.

Key Exclusion Criteria:

• Current medication that may affect accommodation;
• Systemic disease or concomitant medication that may increase operative risk or confound results;
• Ocular conditions that may predispose the subject for future complications;
• Monocular subjects or subjects with significant permanent visual function loss in fellow eye;
• Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
• Grade 4 cataract of any type.