Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
85 participants
INTERVENTIONAL
2025-12-31
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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AAL-FAIOL
The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.
AAL-FAIOL
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.
Phacoemulsification
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
BAL-FAIOL
The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.
BAL-FAIOL
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.
Phacoemulsification
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Interventions
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AAL-FAIOL
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-FAIOL
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.
Phacoemulsification
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
22 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Clinica 20/20
San José, , Costa Rica
Instituto Espaillat Cabral
Santo Domingo, , Dominican Republic
Centro Panamericano de Ojos / Clinica Lopez Beltran
San Salvador, , El Salvador
Panama Eye Center
Panama City, , Panama
Countries
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Central Contacts
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Other Identifiers
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ILK345-E001
Identifier Type: -
Identifier Source: org_study_id