Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

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

Detailed Description
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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.

Official Title
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Clinical Evaluation of the FluidVision Accommodating Intraocular Lens

Conditions
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Aphakia

Intervention / Treatment
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* Device: FluidVision AIOL
* Procedure: Cataract Surgery


Participation Criteria
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Eligibility Criteria
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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.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FluidVision<br>FluidVision AIOL implanted in the capsular bag of the eye during cataract 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>* Performed using standard microsurgical techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accommodative amplitude | Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near. | Month 6 | 
| Best corrected distance visual acuity (BCDVA) | Visual acuity of the eye will be tested with the correction in place. | Month 6 | 
| Rates of adverse events | Adverse events will be collected from time of enrollment to study exit | Up to Month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract