Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
NCT05796453 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 470
Last updated 2025-08-14
Summary
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.
Conditions
- Aphakia
- Astigmatism
- Presbyopia
Interventions
- DEVICE
-
Clareon Vivity IOL - Non Toric
Spherical extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.
- DEVICE
-
Clareon Vivity IOL - Toric
Toric extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.
- DEVICE
-
Clareon PanOptix Trifocal IOL - Non Toric
Spherical trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.
- DEVICE
-
Clareon PanOptix Trifocal IOL - Toric
Toric trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.
Sponsors & Collaborators
-
Alcon Research
lead INDUSTRY
Principal Investigators
-
Clinical Trial Lead, Surgical · Alcon Research, LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-19
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
- FDA Device
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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