Status:

RECRUITING

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

Lead Sponsor:

Alcon Research

Conditions:

Cataract

Eligibility:

All Genders

22+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • Key
  • Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;
  • Willing and able to attend all scheduled study visits as required by the protocol;
  • Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;
  • Other protocol-specified inclusion criteria may apply.
  • Key

Exclusion

  • Subjects taking medications that may affect accommodation;
  • Clinically significant eye abnormalities as specified in the protocol;
  • Previous eye surgery as specified in the protocol;
  • Other protocol-specified exclusion criteria may apply.

Key Trial Info

Start Date :

March 31 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

175 Patients enrolled

Trial Details

Trial ID

NCT05317728

Start Date

March 31 2023

End Date

December 1 2026

Last Update

August 8 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Clinica 20/20

San José, Costa Rica

2

Laser Center SA

Santo Domingo, Dominican Republic, 10124

3

Centro de Retina Medica y Quirurgica SC

Zapopan, Jalisco, Mexico, 45116

4

Asociación Para Evitar la Ceguera en México

Mexico City, Mexico, 04030