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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2026-12-31

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).

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Detailed Description

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In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. 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.

This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.

This study will be conducted in Central America.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cohort 1 utilizes a parallel-group study design. Cohort 2 utilizes a single-group study design.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Cohort 1 is a subject and assessor-masked comparison. Cohort 2 does not utilize masking.

Study Groups

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Cohort 1: BAL-FAIOL

BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)

Group Type EXPERIMENTAL

BAL-FAIOL IOL

Intervention Type DEVICE

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

Cataract surgery

Intervention Type PROCEDURE

Phacoemulsification with a clear cornea incision

Cohort 1: Monofocal

Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)

Group Type ACTIVE_COMPARATOR

Monofocal IOL

Intervention Type DEVICE

Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Cataract surgery

Intervention Type PROCEDURE

Phacoemulsification with a clear cornea incision

Cohort 2: BAL-FAIOL

BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)

Group Type EXPERIMENTAL

BAL-FAIOL IOL

Intervention Type DEVICE

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

Cataract surgery

Intervention Type PROCEDURE

Phacoemulsification with a clear cornea incision

Interventions

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BAL-FAIOL IOL

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

Intervention Type DEVICE

Monofocal IOL

Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Intervention Type DEVICE

Cataract surgery

Phacoemulsification with a clear cornea incision

Intervention Type PROCEDURE

Other Intervention Names

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AcrySof IQ monofocal IOL (SN60WF)

Eligibility Criteria

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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;

Exclusion Criteria

* Subjects taking medications that may affect accommodation;
* Clinically significant eye abnormalities as specified in the protocol;
* Previous eye surgery as specified in the protocol;

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No