Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

Detailed Description
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Eligible subjects will be enrolled into one of two groups: BAL-FAIOL IOL or Monofocal IOL. Both eyes will receive cataract surgery with IOL implantation. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.

Official Title
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Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control

Conditions
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Cataract

Intervention / Treatment
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* Device: BAL-FAIOL IOL
* Device: Monofocal IOL
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form; Willing and able to attend all scheduled study visits as required by the protocol; Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision; Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Subjects taking medications that could increase risk or may affect accommodation; Clinically significant eye abnormalities as specified in the protocol; Previous eye surgery as specified in the protocol; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 22 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: BAL-FAIOL<br>BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation) | Device: BAL-FAIOL IOL<br>* Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject<br>Procedure: Cataract surgery<br>* Phacoemulsification with a clear cornea incision<br>|
| Active Comparator: Monofocal<br>Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation) | Device: Monofocal IOL<br>* Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject<br>* Other names: AcrySof IQ monofocal IOL (SN60WF);Procedure: Cataract surgery<br>* Phacoemulsification with a clear cornea incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) | Distance visual acuity will be measured with correction in place for each eye individually using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR). | Month 6 post second eye implantation | 
| Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) | The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for the BAL-FAIOL IOL only. | Up to Year 1 | 

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