Status:
RECRUITING
Feasibility Study of an Accommodating IOL Design
Lead Sponsor:
Alcon Research
Conditions:
Aphakia
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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.
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 separate...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT07147192
Start Date
December 3 2025
End Date
September 1 2027
Last Update
December 15 2025
Active Locations (5)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
2
Clinica 20/20
San José, Costa Rica
3
Instituto Espaillat Cabral
Santo Domingo, Dominican Republic
4
Centro Panamericano de Ojos / Clinica Lopez Beltran
San Salvador, El Salvador