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

Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: BAL-FAIOL IOL; Procedure: Cataract surgery; Device: Monofocal 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 Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Costa Rica
  • San José, Costa Rica
    • Clinica 20/20
• Dominican Republic
  • Santo Domingo, Dominican Republic, 10124
    • Laser Center SA
• Mexico
  • Mexico City, Mexico, 04030
    • Asociación Para Evitar la Ceguera en México
  • Mexico City, Mexico, 06600
    • Salauno Salud SAPI de CV
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45116
      • Centro de Retina Medica y Quirurgica SC
• Panama
  • Panama City, Panama
    • Panama Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: BAL-FAIOL; BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)	Device: BAL-FAIOL IOL; Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; Procedure: Cataract surgery; Phacoemulsification with a clear cornea incision
Active Comparator: Cohort 1: Monofocal; Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)	Procedure: Cataract surgery; Phacoemulsification with a clear cornea incision; Device: Monofocal IOL; Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject; Other Names: AcrySof IQ monofocal IOL (SN60WF)
Experimental: Cohort 2: BAL-FAIOL; BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)	Device: BAL-FAIOL IOL; Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; Procedure: Cataract surgery; Phacoemulsification with a clear cornea incision

What is the study measuring?

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). This outcome measure is pre-specified for Cohort 1 and Cohort 2.	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 Cohort 1 BAL-FAIOL IOL only.	Up to Year 1
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2	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	Up to Year 1

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: IOL; Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Refractive Surgical Procedures; Cataract Extraction
• Other Study ID Numbers: ILR286-E002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes