Feasibility Study of an Accommodating IOL Design

Alcon

Status: Enrolling

Conditions: Aphakia

Treatments: Device: AAL-FAIOL; Procedure: Phacoemulsification; Device: BAL-FAIOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT07147192

ILK345-E001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

AAL-FAIOL

Experimental group

Description:

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

Treatment:

Procedure: Phacoemulsification

Device: AAL-FAIOL

BAL-FAIOL

Experimental group

Description:

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

Treatment:

Device: BAL-FAIOL

Procedure: Phacoemulsification