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

August 31, 2026 updated by: Alcon Research

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 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.
Month 6 post second eye implantation
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)
Time Frame: 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.
Up to Year 1
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2
Time Frame: 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
Up to Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 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)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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