Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-12 @ 8:01 AM
Study NCT ID:
NCT05317728
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2022-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
Detailed Description:
In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.
This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.
This study will be conducted in Central America.
This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.
This study will be conducted in Central America.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: