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OpenTrials
Completed

NCT Number: NCT05796674

Clareon IOL Retrospective Data Collection

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.

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Key information

Conditions

Aphakia Astigmatism Eye Diseases Lens Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Observational

Primary location

Alcon Research, LLC

Fort Worth, Texas, 76134, United States

About this study

In this retrospective postmarket study, the WaveTec AnalyzOR Database will be reviewed. All available data that meet the data selection criteria as of the data cutoff will be analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Data Selection Criteria (eyes):

  • Must have undergone cataract extraction by phacoemulsification with implantation of a Clareon UVA IOL (CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, or CCA0T0) using the WaveTec ORA System.
  • Must have a BCDVA in the WaveTec AnalyzOR Database from ≥ 10 days after surgery.
  • Predicted residual refractive error spherical equivalent (SE) ≤ 0.75 D.

Treatment and study plan

Clareon UVA IOL

Device

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.

Other names: Models CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, CCA0T0

WaveTec Optiwave Refractive Analysis (ORA) System

Device

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

cataract surgery

Procedure

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

Primary outcomes

  1. Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit

    Time frame: Month 1 postoperative

    The database will be reviewed for assessments of monocular (by-eye) best corrected distance visual acuity at the first postoperative visit. The first postoperative visit will be defined as the visit which occurred approximately 28 days or later from the operative visit during which time the IOL remained implanted in the eye and an eye exam was performed.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Post Market Clinical Follow-up (PMCF) Pilot Study for the Clareon UVA IOLs Using Retrospective Data Collection From the WaveTec AnalyzOR Database

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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