Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

Clinical Evaluation of the FluidVision Accommodating Intraocular Lens

The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.

Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.

Key Inclusion Criteria:

• Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
• Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
• Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;
• Willing and able to comply with schedule for follow-up visits for 36 months after surgery.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);
• Taking systemic medications that may confound the outcome or increase the risk to the subject;
• Ocular conditions that may predispose for future complications;
• Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;
• Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
• Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
• Other protocol-defined exclusion criteria may apply.