NCT05317728

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).

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
4 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

March 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

March 31, 2022

Last Update Submit

February 9, 2026

Conditions

Cataract

Keywords

IOLIntraocular lens

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Cohort 1: BAL-FAIOL

EXPERIMENTAL

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

Device: BAL-FAIOL IOLProcedure: Cataract surgery

Cohort 1: Monofocal

ACTIVE COMPARATOR

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

Device: Monofocal IOLProcedure: Cataract surgery

Cohort 2: BAL-FAIOL

EXPERIMENTAL

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

Device: BAL-FAIOL IOLProcedure: Cataract surgery

Interventions

BAL-FAIOL IOLDEVICE

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

Cohort 1: BAL-FAIOLCohort 2: BAL-FAIOL
Monofocal IOLDEVICE

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

Also known as: AcrySof IQ monofocal IOL (SN60WF)
Cohort 1: Monofocal
Cataract surgeryPROCEDURE

Phacoemulsification with a clear cornea incision

Cohort 1: BAL-FAIOLCohort 1: MonofocalCohort 2: BAL-FAIOL

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Subjects taking medications that may affect accommodation;
  • Clinically significant eye abnormalities as specified in the protocol;
  • Previous eye surgery as specified in the protocol;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinica 20/20

San José, Costa Rica

Location

Laser Center SA

Santo Domingo, 10124, Dominican Republic

Location

Centro de Retina Medica y Quirurgica SC

Zapopan, Jalisco, 45116, Mexico

Location

Asociación Para Evitar la Ceguera en México

Mexico City, 04030, Mexico

Location

Salauno Salud SAPI de CV

Mexico City, 06600, Mexico

Location

Panama Eye Center

Panama City, Panama

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Clinical Trial Lead, Surgical

    Alcon Research, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Cohort 1 is a subject and assessor-masked comparison. Cohort 2 does not utilize masking.
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: Cohort 1 utilizes a parallel-group study design. Cohort 2 utilizes a single-group study design.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 8, 2022

Study Start

March 31, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(3)CO(1)DO(1)PA(1)