NCT05317728

Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design

Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	BAL-FAIOL IOL	Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
DEVICE	Monofocal IOL	Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
PROCEDURE	Cataract surgery	Phacoemulsification with a clear cornea incision

Timeline

• Start date: 2023-03-31
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-04-08
• Last updated: 2026-02-10

Locations

6 sites across 4 countries: Costa Rica, Dominican Republic, Mexico, Panama

Regulatory

• FDA-regulated device study