Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

Study Overview
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Brief Summary
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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
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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.

Official Title
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CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration

Conditions
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Cataract

Intervention / Treatment
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* Device: FluidVision AIOL
* Device: AcrySof IQ PanOptix Trifocal IOL
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FluidVision<br>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. | Device: FluidVision AIOL<br>* Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject<br>Procedure: Cataract surgery<br>* Cataract surgery per investigator's standard practice<br>|
| Active Comparator: PanOptix<br>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. | Device: AcrySof IQ PanOptix Trifocal IOL<br>* Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject<br>* Other names: PanOptix;Procedure: Cataract surgery<br>* Cataract surgery per investigator's standard practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye | Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place. | Month 6 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye | Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place. | Month 6 postoperative | 
| Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye | Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place. | Month 6 postoperative | 
| Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve | A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear. | Month 6 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular lens, Eye surgery