Feasibility Study of an Accommodating IOL Design
Alcon Research
85 participants
Dec 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria4
- 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.
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Interventions
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.
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.
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07147192