Feasibility Study of an Accommodating IOL Design

Not Applicable

Not yet recruiting

• Conditions: Aphakia

• Registration Number: NCT07147192
• Lead Sponsor: Alcon Research

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 separated by 14-35 days. Subjects will attend follow up visits for approximately 1 year. If needed, the AAL lens may be adjusted after surgery with a laser to help give the participant better vision.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-09-04
• Study Start: 2025-11-01
• Primary Completion: 2027-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)	From Day 0 up to Month 12	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.

Trial Locations

Locations (4)

Clinica 20/20; 🇨🇷 San José, Costa Rica

Instituto Espaillat Cabral; 🇩🇴 Santo Domingo, Dominican Republic

Centro Panamericano de Ojos / Clinica Lopez Beltran; 🇸🇻 San Salvador, El Salvador

Panama Eye Center; 🇵🇦 Panama City, Panama