MedTrace Logo

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

NCT05317728 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-02-10

No results posted yet for this study

Summary

The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

Conditions

  • Cataract

Interventions

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Trial Lead, Surgical · Alcon Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Costa Rica
  • Dominican Republic
  • Mexico
  • Panama

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317728 on ClinicalTrials.gov