Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

Launched by POWERVISION · Apr 16, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.