NCT07147192

Feasibility Study of an Accommodating IOL Design

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aphakia

Interventions

Type	Name	Description
DEVICE	AAL-FAIOL	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.
DEVICE	BAL-FAIOL	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.
PROCEDURE	Phacoemulsification	Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-04-01
• Completion: 2027-11-01
• First posted: 2025-08-29
• Last updated: 2026-03-24

Locations

5 sites across 5 countries: United States, Costa Rica, Dominican Republic, El Salvador, Panama

Regulatory

• FDA-regulated device study