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Active, Not Recruiting

NCT Number: NCT05317728

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica 20/20, San José, Costa Rica

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAL-FAIOL IOL

Device

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

Monofocal IOL

Device

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

Other names: AcrySof IQ monofocal IOL (SN60WF)

cataract surgery

Procedure

Phacoemulsification with a clear cornea incision

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2022
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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