Clareon IOL Retrospective Data Collection

NCT ID: NCT05796674

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1090 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-18

Study Completion Date

2023-09-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aphakia Astigmatism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Clareon UVA IOL

Eyes that underwent cataract surgery and received a Clareon UVA IOL with the use of the WaveTec Optiwave Refractive Analysis (ORA) System

Clareon UVA IOL

Intervention Type 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.

WaveTec Optiwave Refractive Analysis (ORA) System

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Cataract surgery

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

Intervention Type PROCEDURE

Other Intervention Names

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Models CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, CCA0T0

Eligibility Criteria

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Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Lead, Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Research, LLC

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ILS241-R001

Identifier Type: -

Identifier Source: org_study_id

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