An interventional study of AAL-FAIOL and BAL-FAIOL in Aphakia, sponsored by Alcon Research. Active, not recruiting at 4 sites in 4 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Alcon Research · Not applicable, Interventional, and Device feasibility
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.
Device: AAL-FAIOL · Procedure: Phacoemulsification
The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.
Device: BAL-FAIOL · Procedure: Phacoemulsification
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.
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.
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
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.
Time frame: From Day 0 up to Month 12
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Alcon Research