Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL) With an Improved Injector System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical outcomes of an investigational IOL in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.

Official Title
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Clinical Evaluation of the FluidVision Accommodating Intraocular Lens With an Improved Injector System

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. An improved injector system was used.<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