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
Cohortes
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
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.
Clareon Vivity IOL - Toric
État du recrutement
unknown
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.
Clareon PanOptix IOL - Non Toric
État du recrutement
unknown
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.
Clareon PanOptix IOL - Toric
État du recrutement
unknown
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.
Données à jour depuis :
16 août 2023
Description de l'étude
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
Centres participants
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
Source d'information
Dernière modification :
16 août 2023
Données à jour depuis :
21 mars
Origine des données :
clinicaltrials.gov