An interventional study of BAL-FAIOL IOL and Monofocal IOL in Cataract, sponsored by Alcon Research. Active, not recruiting at 6 sites in 4 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Device feasibility
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.
This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.
This study will be conducted in Central America.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 175 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Device: BAL-FAIOL IOL · Procedure: Cataract surgery
Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
Device: Monofocal IOL · Procedure: Cataract surgery
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Device: BAL-FAIOL IOL · Procedure: Cataract surgery
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Also known as: AcrySof IQ monofocal IOL (SN60WF)
Phacoemulsification with a clear cornea incision
Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)
Distance visual acuity will be measured with correction in place for each eye individually using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR). This outcome measure is pre-specified for Cohort 1 and Cohort 2.
Time frame: Month 6 post second eye implantation
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)
The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for Cohort 1 BAL-FAIOL IOL only.
Time frame: Up to Year 1
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2
The number of adverse events, including SSI's, will be calculated from time of implantation. The outcome measure is pre-specified for Cohort 2 only
Time frame: Up to Year 1
Plan to share: No
No publications or documents are linked to this record.
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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