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

Not Applicable

Recruiting

• Conditions: Cataract
• Interventions: Device: BAL-FAIOL IOL; Device: Monofocal IOL; Procedure: Cataract surgery

• Registration Number: NCT05317728
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Study Start: 2023-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAL-FAIOL	BAL-FAIOL IOL	BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
BAL-FAIOL	Cataract surgery	BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Monofocal	Monofocal IOL	Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
Monofocal	Cataract surgery	Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)

Primary Outcome Measures

Name	Time	Method
Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)	Month 6 post second eye implantation	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). This outcome measure is pre-specified for Cohort 1 and Cohort 2.
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)	Up to Year 1	The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for Cohort 1 BAL-FAIOL IOL only.
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2	Up to Year 1	The number of adverse events, including SSI's, will be calculated from time of implantation. The outcome measure is pre-specified for Cohort 2 only

Trial Locations

Locations (6)

Clinica 20/20; 🇨🇷 San José, Costa Rica

Laser Center SA; 🇩🇴 Santo Domingo, Dominican Republic

Centro de Retina Medica y Quirurgica SC; 🇲🇽 Zapopan, Jalisco, Mexico

Asociación Para Evitar la Ceguera en México; 🇲🇽 Mexico City, Mexico

Salauno Salud SAPI de CV; 🇲🇽 Mexico City, Mexico

Panama Eye Center; 🇵🇦 Panama, Panama