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Status:

RECRUITING

Feasibility Study of an Accommodating IOL Design

Lead Sponsor:

Alcon Research

Conditions:

Aphakia

Eligibility:

All Genders

22+ years

Phase:

NA

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.

Detailed Description

This study will enroll adult subjects who require cataract surgery in both eyes. One eye will receive the AAL-FAIOL and the other eye will receive the BAL-FAIOL. The two eye surgeries will be separate...

Eligibility Criteria

Inclusion

  • Key
  • 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.
  • Other protocol-defined inclusion criteria may apply.
  • Key

Exclusion

  • 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.
  • Other protocol-defined exclusion criteria may apply.

Key Trial Info

Start Date :

December 3 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

85 Patients enrolled

Trial Details

Trial ID

NCT07147192

Start Date

December 3 2025

End Date

September 1 2027

Last Update

December 15 2025

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States, 76134

2

Clinica 20/20

San José, Costa Rica

3

Instituto Espaillat Cabral

Santo Domingo, Dominican Republic

4

Centro Panamericano de Ojos / Clinica Lopez Beltran

San Salvador, El Salvador