Feasibility Study of an Accommodating IOL Design (NCT07147192) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility Study of an Accommodating IOL Design
United States, Costa Rica, Dominican Republic85 participantsStarted 2025-12-03
Plain-language 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.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)