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.
| Condition(s) | Aphakia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 e |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | Alcon Research |
| Locations | San José, Costa Rica; Santo Domingo, Dominican Republic; San Salvador, El Salvador; Panama City, Panama |
| Start date | 2025-12-03 |
| NCT ID | NCT07147192 |
| Official listing | https://clinicaltrials.gov/study/NCT07147192 |