Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAL-FAIOL | Experimental | The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye. |
|
| BAL-FAIOL | Experimental | The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAL-FAIOL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs) | The number of adverse events, including SSI's, will be calculated. An SSI is a subsequent operation performed to address issues or complications arising from a previous surgical procedure. AEs will be collected starting at Day 0 after informed consent. SSIs will be collected starting Day 1. | From Day 0 up to Month 12 |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alcon Call Center | Contact | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica 20/20 | Recruiting | San José | Costa Rica | |||
| Instituto Espaillat Cabral |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Contralateral implantation
Not provided
Not provided
Not provided
Not provided
|
| BAL-FAIOL | Device | 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 | Procedure | Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation. |
|
| Not yet recruiting |
| Santo Domingo |
| Dominican Republic |
| Centro Panamericano de Ojos / Clinica Lopez Beltran | Not yet recruiting | San Salvador | El Salvador |
| Panama Eye Center | Recruiting | Panama City | Panama |
| D059708 | Ultrasonic Surgical Procedures |