CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PowerVision
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
FluidVision
FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
Intervention: FluidVision AIOL (Device)
FluidVision
FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
Intervention: Cataract surgery (Procedure)
PanOptix
Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
Intervention: Cataract surgery (Procedure)
PanOptix
Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
Intervention: AcrySof IQ PanOptix Trifocal IOL (Device)
Outcomes
Primary Outcomes
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
Time Frame: Month 6 postoperative
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Secondary Outcomes
- Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye(Month 6 postoperative)
- Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye(Month 6 postoperative)
- Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve(Month 6 postoperative)