Feasibility Study of an Accommodating IOL Design

Feasibility Study of an Accommodating IOL Design

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.

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.