Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Costa Rica
Clinica 20/20
RECRUITING
San José
Dominican Republic
Laser Center SA
COMPLETED
Santo Domingo
Mexico
Asociación Para Evitar la Ceguera en México
ACTIVE_NOT_RECRUITING
Mexico City
Salauno Salud SAPI de CV
ACTIVE_NOT_RECRUITING
Mexico City
Centro de Retina Medica y Quirurgica SC
ACTIVE_NOT_RECRUITING
Zapopan
Panama
Panama Eye Center
RECRUITING
Panama City
Contact Information
Primary
Alcon Call Center
alcon.medinfo@alcon.com
1-888-451-3937
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 175
Treatments
Experimental: Cohort 1: BAL-FAIOL
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Active_comparator: Cohort 1: Monofocal
Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
Experimental: Cohort 2: BAL-FAIOL
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
Related Therapeutic Areas
Sponsors
Leads: Alcon Research