Feasibility Study of an Accommodating IOL Design
Alcon Research
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.
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Key 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. Key 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.…
Interventions
- DeviceAAL-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.
- DeviceBAL-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.
- ProcedurePhacoemulsification
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Locations (5)
- Contact Alcon Call Center for Trial LocationsFort Worth, Texas
- Clinica 20/20San José
- Instituto Espaillat CabralSanto Domingo
- Centro Panamericano de Ojos / Clinica Lopez BeltranSan Salvador
- Panama Eye CenterPanama City