Feasibility Study of an Accommodating IOL Design
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AAL-FAIOL, BAL-FAIOL, Phacoemulsification.
- Who it may be relevant to
- Registry conditions: Aphakia. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Costa Rica, Dominican Republic, El Salvador, Panama
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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. - Device 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. - Procedure Phacoemulsification
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Primary outcome measures
- Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs) [Time frame: From Day 0 up to Month 12]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Costa Rica · 1 center
- Clinica 20/20 — San José
Dominican Republic · 1 center
- Instituto Espaillat Cabral — Santo Domingo
El Salvador · 1 center
- Centro Panamericano de Ojos / Clinica Lopez Beltran — San Salvador
Panama · 1 center
- Panama Eye Center — Panama City
Identifiers
NCT: NCT07147192 · ILK345-E001