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.
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
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.
- 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.