AphakiaNCT07147192
Feasibility Study of an Accommodating IOL Design
A study testing AAL-FAIOL, BAL-FAIOL and Phacoemulsification in people with Aphakia, run by Alcon Research at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia
- What is being tested?
- AAL-FAIOL, BAL-FAIOL and Phacoemulsification
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 3 Dec 2025to Oct 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 Informed Consent Form.
- Willing and able to attend all scheduled study visits required per protocol.
- Diagnosed with bilateral cataracts requiring removal by phacoemulsification.
- Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding.
- Taking medications that could increase risk or may affect accommodation.
- Eye conditions as specified in the protocol, including glaucoma or ocular hypertension.
- Medical conditions that could increase operative risk as specified in the protocol.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
El Salvador1 site
Centro Panamericano de Ojos / Clinica Lopez Beltran
San Salvador
About this study
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.
Read the 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
- Being tested
- AAL-FAIOL, BAL-FAIOL, Phacoemulsification
- Keywords
- Cataract
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAL-FAIOLDevice
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.
BAL-FAIOLDevice
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.
PhacoemulsificationProcedure or surgery
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
| Study group | Role | What they receive |
|---|---|---|
| AAL-FAIOL | Experimental | The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye. Receives: Device: AAL-FAIOL; Procedure: Phacoemulsification |
| BAL-FAIOL | Experimental | The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye. Receives: Device: BAL-FAIOL; Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 0 up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start3 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Contralateral implantation
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
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
- NCT07147192
- Sponsor's protocol ID
- ILK345-E001
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2025
- Last updated
- 2 Sep 2026
- Results posted
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Accommodating IOL Design
- ClinicalTrials.gov ID
- NCT07147192
- Acronym / sponsor ID
- ILK345-E001
- Conditions
- Aphakia
- Keywords
- Cataract
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Aug 2025 (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 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Contralateral implantation
| Arm | Type | Receives |
|---|---|---|
| AAL-FAIOL | Experimental | Device: AAL-FAIOL, Procedure: PhacoemulsificationThe clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye. |
| BAL-FAIOL | Experimental | Device: BAL-FAIOL, Procedure: PhacoemulsificationThe clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and sign an Informed Consent Form.
- Willing and able to attend all scheduled study visits required per protocol.
- Diagnosed with bilateral cataracts requiring removal by phacoemulsification.
- Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding.
- Taking medications that could increase risk or may affect accommodation.
- Eye conditions as specified in the protocol, including glaucoma or ocular hypertension.
- Medical conditions that could increase operative risk as specified in the protocol.
- Other protocol-defined 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 |
|---|---|---|
| AAL-FAIOLIntraocular 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 | AAL-FAIOL |
| BAL-FAIOLIntraocular 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. | Device | BAL-FAIOL |
| PhacoemulsificationCataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation. | Procedure or surgery | AAL-FAIOL, BAL-FAIOL |
Primary outcome
Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)
Time frame: From Day 0 up to Month 12
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.
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 2 Sep 2026.
- EducationalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAL-FAIOL, BAL-FAIOL and Phacoemulsification in people with Aphakia, run by Alcon Research at 4 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 5 inclusion and 5 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 2 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 4 sites in Costa Rica, Dominican Republic, El Salvador, 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?
Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs) (time frame: From Day 0 up to Month 12). 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 2 Sep 2026.