Clareon IOL Retrospective Data Collection

NCT05796674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1090

Last updated 2023-10-18

No results posted yet for this study

Summary

The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.

Conditions

  • Aphakia
  • Astigmatism

Interventions

DEVICE

Clareon UVA IOL

Clareon UVA IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery to replace the natural crystalline lens. Models CC60WF and CCA0T0 are indicated for the visual correction of aphakia. Models CCW0T3, CCW0T4, CCW0T5, and CCW0T6 are indicated for the visual correction of aphakia and preexisting corneal astigmatism.

DEVICE

WaveTec Optiwave Refractive Analysis (ORA) System

Intra-operative system used during refractive cataract surgery to capture wavefront images of the patient's eye for the purpose of optimizing IOL implantation

PROCEDURE

Cataract surgery

Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Lead, Surgical · Alcon Research, LLC

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2023-09-12
Completion
2023-09-12
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05796674 on ClinicalTrials.gov