Back to resultsPost Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
Primary Purpose
Aphakia, Astigmatism, Presbyopia
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clareon Vivity IOL - Non Toric
Clareon Vivity IOL - Toric
Clareon PanOptix Trifocal IOL - Non Toric
Clareon PanOptix Trifocal IOL - Toric
Sponsored by
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
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Clareon Vivity IOL - Non Toric
Clareon Vivity IOL - Toric
Clareon PanOptix IOL - Non Toric
Clareon PanOptix IOL - Toric
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit
BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).
Rate of Adverse Events
Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following:
Cystoid Macular Edema (CME)
Hypopyon
Endophthalmitis
Lens dislocation
Pupillary Block
Retinal Detachment
Secondary Surgical Interventions (Explantation/exchange/repositioning)
Rate of Device Deficiencies
Device deficiencies will be assessed at each prospective visit. Examples include the following:
Failure to meet product specifications (e.g., incorrect IOL power)
IOL defect
Broken IOL optic
Broken IOL haptic
Scratched IOL optic
Unsealed device packaging
Suspected product contamination
Lack of performance
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05796453
Brief Title
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
Official Title
Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Astigmatism, Presbyopia
Keywords
Cataract surgery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clareon Vivity IOL - Non Toric
Arm Type
Experimental
Arm Description
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.
Arm Title
Clareon Vivity IOL - Toric
Arm Type
Experimental
Arm Description
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.
Arm Title
Clareon PanOptix IOL - Non Toric
Arm Type
Experimental
Arm Description
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.
Arm Title
Clareon PanOptix IOL - Toric
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Clareon Vivity IOL - Non Toric
Other Intervention Name(s)
Models CNWET0, CCWET0
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Clareon Vivity IOL - Toric
Other Intervention Name(s)
Models CNWET2, CNWET3, CNWET4, CNWET5, CNWET6, CCWET-2, CCWET3, CCWET4, CCWET3, CCWET3-T6
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Clareon PanOptix Trifocal IOL - Non Toric
Other Intervention Name(s)
Model CNWTT0, CCWTT2
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Clareon PanOptix Trifocal IOL - Toric
Other Intervention Name(s)
Models CNWTT2, CNWTT3, CNWTT4, CNWTT5, CNWTT6, CCWTT2, CCWTT3, CCWTT4, CCWTT5, and CCWTT6
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit
Description
BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).
Time Frame
Up to Year 3
Title
Rate of Adverse Events
Description
Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following:
Cystoid Macular Edema (CME)
Hypopyon
Endophthalmitis
Lens dislocation
Pupillary Block
Retinal Detachment
Secondary Surgical Interventions (Explantation/exchange/repositioning)
Time Frame
Up to Year 3
Title
Rate of Device Deficiencies
Description
Device deficiencies will be assessed at each prospective visit. Examples include the following:
Failure to meet product specifications (e.g., incorrect IOL power)
IOL defect
Broken IOL optic
Broken IOL haptic
Scratched IOL optic
Unsealed device packaging
Suspected product contamination
Lack of performance
Time Frame
Up to Year 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alcon Call Center
Phone
1-888-451-3937
Email
alcon.medinfo@alcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Surgeons of CNY
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulsa Ophthalmology
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
Chu Eye Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Recruiting
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro Oftalmologico Metropolitano
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
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