Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration

The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.

Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.

Key Inclusion Criteria:

• Require cataract extraction by phacoemulsification;
• Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;
• Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.

Key Exclusion Criteria:

• Use of current medications that may affect accommodation or confound study results;
• Systemic disease that may increase the operative risk or confound results;
• Ocular conditions or degenerative disorders that may predispose the subject to future complications;
• Monocular subjects or significant permanent visual function loss in 1 eye;
• Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.