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ILE632-I001

Post market clinical follow-up (pmcf) study of clareon vivity & clareon panoptix
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05796453
Cataract surgery
Source : Importé depuis le centre
Aphakia
Astigmatism
Presbyopia
Recrutement à venir
Dernière modification : 2023/08/16

Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Aphakia

Astigmatism

Presbyopia

Source : Importé depuis le centre

Profil des participants

Sexe(s) des participants

All

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Key Inclusion Criteria:

Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

Subject is currently participating in another investigational drug or device study.
Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
Subject is pregnant at the time of enrollment.
Other protocol-defined exclusion criteria may apply.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Clareon Vivity IOL - Non Toric Donnée non disponible Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL.
  • Inconnu
  • Clareon Vivity IOL - Toric Donnée non disponible Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL.
  • Inconnu
  • Clareon PanOptix IOL - Non Toric Donnée non disponible Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL.
  • Inconnu
  • Clareon PanOptix IOL - Toric Donnée non disponible Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL.
  • Inconnu
  • Clareon Vivity IOL - Non Toric
    État du recrutement
    unknown
    Clareon Vivity IOL - Toric
    État du recrutement
    unknown
    Clareon PanOptix IOL - Non Toric
    État du recrutement
    unknown
    Clareon PanOptix IOL - Toric
    État du recrutement
    unknown
    Données à jour depuis : 16 août 2023

    Description de l'étude

    Résumé de l'étude

    The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.

    Source : Importé depuis le centre

    Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.

    Source : Importé depuis le centre

    Sites

    Centres participants

      7 centres
    • CENTRO OFTALMOLOGICO METROPOLITANO

      San juan

      PUERTO RICO

      Recrutement local
      État du recrutement: À VENIR
    • CHU EYE INSTITUTE

      Fort worth

      TEXAS, UNITED STATES

      Recrutement local
      État du recrutement: À VENIR
    • EYE SURGEONS OF CNY

      Liverpool

      NEW YORK, UNITED STATES

      Recrutement local
      État du recrutement: À VENIR
    • LEVENSON EYE ASSOCIATES

      Jacksonville

      FLORIDA, UNITED STATES

      Recrutement local
      État du recrutement: À VENIR
    • THE EYE INSTITUTE OF UTAH

      Salt lake city

      UTAH, UNITED STATES

      Recrutement local
      État du recrutement: À VENIR
    • TULSA OPHTHALMOLOGY

      Tulsa

      OKLAHOMA, UNITED STATES

      Recrutement local
      État du recrutement: À VENIR
    • WOLSTAN & GOLDBERG EYE ASSOCIATES

      Torrance

      CALIFORNIA, UNITED STATES

      Recrutement local
      État du recrutement: À VENIR

    Dernière modification : 16 août 2023
    Données à jour depuis : 21 mars
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05796453