NCT07147192

Brief Summary

The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will be conducted in Central America.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
5 countries

5 active sites

Status
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 Progress22%
Dec 2025Nov 2027

First Submitted

Initial submission to the registry

August 27, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

August 27, 2025

Last Update Submit

March 23, 2026

Conditions

Aphakia

Keywords

Cataract

Outcome Measures

Primary Outcomes (1)

  • Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)

    The number of adverse events, including SSI's, will be calculated. An SSI is a subsequent operation performed to address issues or complications arising from a previous surgical procedure. AEs will be collected starting at Day 0 after informed consent. SSIs will be collected starting Day 1.

    From Day 0 up to Month 12

Study Arms (2)

AAL-FAIOL

EXPERIMENTAL

The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.

Device: AAL-FAIOLProcedure: Phacoemulsification

BAL-FAIOL

EXPERIMENTAL

The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.

Device: BAL-FAIOLProcedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.

AAL-FAIOLBAL-FAIOL
AAL-FAIOLDEVICE

Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject. Laser energy to specified locations can be used to allow a change in power for far distances.

AAL-FAIOL
BAL-FAIOLDEVICE

Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.

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 Informed Consent Form.
  • Willing and able to attend all scheduled study visits required per protocol.
  • Diagnosed with bilateral cataracts requiring removal by phacoemulsification.
  • Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes.

You may not qualify if:

  • Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding.
  • Taking medications that could increase risk or may affect accommodation.
  • Eye conditions as specified in the protocol, including glaucoma or ocular hypertension.
  • Medical conditions that could increase operative risk as specified in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

NOT YET RECRUITING

Clinica 20/20

San José, Costa Rica

RECRUITING

Instituto Espaillat Cabral

Santo Domingo, Dominican Republic

NOT YET RECRUITING

Centro Panamericano de Ojos / Clinica Lopez Beltran

San Salvador, El Salvador

NOT YET RECRUITING

Panama Eye Center

Panama City, Panama

RECRUITING

MeSH Terms

Conditions

AphakiaCataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Clinical Trial Lead, Surgical

    Alcon Research, LLC

    STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

1-888-451-3937alcon.medinfo@alcon.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: Contralateral implantation
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2025

First Posted

August 29, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

DO(1)EL(1)PA(1)US(1)CO(1)