CataractNCT05317728
Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design
A study testing BAL-FAIOL IOL, Monofocal IOL and Cataract surgery in people with Cataract, run by Alcon Research at 6 sites in 4 countries.
Trial summary
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- BAL-FAIOL IOL, Monofocal IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 31 Mar 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;
- Willing and able to attend all scheduled study visits as required by the protocol;
- Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Subjects taking medications that may affect accommodation;
- Clinically significant eye abnormalities as specified in the protocol;
- Previous eye surgery as specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Mexico3 sites
Asociación Para Evitar la Ceguera en México
Mexico City, 04030
Salauno Salud SAPI de CV
Mexico City, 06600
Centro de Retina Medica y Quirurgica SC
Zapopan, Jalisco, 45116
About this study
Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
Read the detailed description
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.
- Conditions
- Cataract
- Being tested
- BAL-FAIOL IOL, Monofocal IOL, Cataract surgery
- Keywords
- IOL, Intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAL-FAIOL IOLDevice
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Monofocal IOLDevice
Also called AcrySof IQ monofocal IOL (SN60WF)
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Cataract surgeryProcedure or surgery
Phacoemulsification with a clear cornea incision
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: BAL-FAIOL | Experimental | BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation) Receives: Device: BAL-FAIOL IOL; Procedure: Cataract surgery |
| Cohort 1: Monofocal | Active comparator | Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation) Receives: Device: Monofocal IOL; Procedure: Cataract surgery |
| Cohort 2: BAL-FAIOL | Experimental | BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation) Receives: Device: BAL-FAIOL IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Up to Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start31 Mar 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1 utilizes a parallel-group study design. Cohort 2 utilizes a single-group study design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317728
- Sponsor's protocol ID
- ILR286-E002
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
- ClinicalTrials.gov ID
- NCT05317728
- Acronym / sponsor ID
- ILR286-E002
- Conditions
- Cataract
- Keywords
- IOL, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Cohort 1 utilizes a parallel-group study design. Cohort 2 utilizes a single-group study design.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: BAL-FAIOL | Experimental | Device: BAL-FAIOL IOL, Procedure: Cataract surgeryBAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation) |
| Cohort 1: Monofocal | Active comparator | Device: Monofocal IOL, Procedure: Cataract surgeryMonofocal IOL implanted in both eyes during cataract surgery (bilateral implantation) |
| Cohort 2: BAL-FAIOL | Experimental | Device: BAL-FAIOL IOL, Procedure: Cataract surgeryBAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;
- Willing and able to attend all scheduled study visits as required by the protocol;
- Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Subjects taking medications that may affect accommodation;
- Clinically significant eye abnormalities as specified in the protocol;
- Previous eye surgery as specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAL-FAIOL IOLInvestigational implantable medical device intended for long-term use over the lifetime of the cataract subject | Device | Cohort 1: BAL-FAIOL, Cohort 2: BAL-FAIOL |
| Monofocal IOLAlso: AcrySof IQ monofocal IOL (SN60WF)Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject | Device | Cohort 1: Monofocal |
| Cataract surgeryPhacoemulsification with a clear cornea incision | Procedure or surgery | Cohort 1: BAL-FAIOL, Cohort 1: Monofocal, Cohort 2: BAL-FAIOL |
Primary outcome
Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)
Time frame: Month 6 post second eye implantation
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.
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)
Time frame: Up to Year 1
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.
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2
Time frame: Up to Year 1
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Surgical study director
Alcon Research, LLC
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAL-FAIOL IOL, Monofocal IOL and Cataract surgery in people with Cataract, run by Alcon Research at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Mexico, Costa Rica, Dominican Republic, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) (time frame: Month 6 post second eye implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.