Feasibility Study of an Accommodating IOL Design

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Contact Alcon Call Center for Trial Locations
NOT_YET_RECRUITING
Fort Worth
Other Locations
Costa Rica
Clinica 20/20
NOT_YET_RECRUITING
San José
Dominican Republic
Instituto Espaillat Cabral
NOT_YET_RECRUITING
Santo Domingo
El Salvador
Centro Panamericano de Ojos / Clinica Lopez Beltran
NOT_YET_RECRUITING
San Salvador
Panama
Panama Eye Center
RECRUITING
Panama City
Contact Information
Primary
Alcon Call Center
alcon.medinfo@alcon.com
1-888-451-3937
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2027-09
Participants
Target number of participants: 85
Treatments
Experimental: AAL-FAIOL
The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.
Experimental: BAL-FAIOL
The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.
Related Therapeutic Areas
Sponsors
Leads: Alcon Research

This content was sourced from clinicaltrials.gov