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Clareon IOL Retrospective Data Collection

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05796674
Collaborator
(none)
300
Enrollment
1
Location
30
Anticipated Duration (Days)
304.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Clareon UVA IOL
  • Device: WaveTec Optiwave Refractive Analysis (ORA) System
  • Procedure: Cataract surgery

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Post Market Clinical Follow-up (PMCF) Pilot Study for the Clareon UVA IOLs Using Retrospective Data Collection From the WaveTec AnalyzOR Database
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

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.
Other Names:
  • Models CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, CCA0T0

    • 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

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Research, LLC Fort Worth Texas United States 76134

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Lead, Surgical, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05796674
    Other Study ID Numbers:
    • ILS241-R001
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 3, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Astigmatism
    Aphakia

    Study Results

    No Results Posted as of Apr 3, 2023