An interventional study of AAL-FAIOL and BAL-FAIOL in Aphakia, sponsored by Alcon Research. Terminated at 4 sites in 4 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Device feasibility
Management Decision
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 17 is below the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Management Decision
Management Decision
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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