VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

Study Overview
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Brief Summary
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The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.

Detailed Description
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This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Official Title
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VisiOn Restoration With the FluidVisION AIOL

Conditions
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Cataract

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity; Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D); Calculated IOL power within range. Key Exclusion Criteria: Current medication that may affect accommodation; Systemic disease or concomitant medication that may increase operative risk or confound results; Ocular conditions that may predispose the subject for future complications; Monocular subjects or subjects with significant permanent visual function loss in fellow eye; Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye; Grade 4 cataract of any type.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral<br>Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated. | 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>* Standard cataract extraction with phacoemulsification<br>|
| Experimental: Contralateral<br>Implantation with the FluidVision AIOL in the first eye during cataract surgery, followed by implantation with the AcrySof IQ monofocal IOL in the fellow eye during a subsequent cataract surgery | Device: FluidVision AIOL<br>* Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject<br>Device: AcrySof IQ monofocal IOL<br>* Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject<br>Procedure: Cataract surgery<br>* Standard cataract extraction with phacoemulsification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accommodative Amplitude (AA) | Accommodative amplitude is the ability of the eye to change its focus from distant to near objects. | Month 6 postoperative | 
| Distance Corrected Visual Acuity | Visual acuity was measured with distance correction (plus or minus power) in place. | Month 6 postoperative | 
| International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL | Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations. | Up to Month 6 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accommodative Amplitude | Accommodative amplitude is a measure of the range of vision with good acuity. | Month 3 postoperative | 
| Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity | Plus lenses were placed over the subject's best distance manifest correction. | Up to Month 6 postoperative | 
| Uncorrected Visual Acuity | Visual acuity was measured without correction in place. | Up to Month 6 postoperative |