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

Alcon

Status: Enrolling

Conditions: Cataract

Treatments: Device: Monofocal IOL; Procedure: Cataract surgery; Device: BAL-FAIOL IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05317728

ILR286-E002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 3 patient groups

Cohort 1: BAL-FAIOL

Experimental group

Description:

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

Treatment:

Device: BAL-FAIOL IOL

Procedure: Cataract surgery

Cohort 1: Monofocal

Active Comparator group

Description:

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

Treatment:

Procedure: Cataract surgery

Device: Monofocal IOL

Cohort 2: BAL-FAIOL

Experimental group

Description:

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

Treatment:

Device: BAL-FAIOL IOL

Procedure: Cataract surgery