Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
Aphakia, Astigmatism, Presbyopia
About this trial
This is an interventional basic science trial for Aphakia focused on measuring Cataract surgery
Eligibility Criteria
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.
Sites / Locations
- Wolstan & Goldberg Eye AssociatesRecruiting
- Levenson Eye AssociatesRecruiting
- Eye Surgeons of CNYRecruiting
- Tulsa OphthalmologyRecruiting
- Chu Eye InstituteRecruiting
- The Eye Institute of UtahRecruiting
- Centro Oftalmologico MetropolitanoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Clareon Vivity IOL - Non Toric
Clareon Vivity IOL - Toric
Clareon PanOptix IOL - Non Toric
Clareon PanOptix IOL - Toric
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.
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.
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.
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.