Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix

Presbyopia Clinical Trial

Official title:

Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796453
• Other study ID #: ILE632-I001
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Astigmatism
• Presbyopia

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	Centro Oftalmologico Metropolitano	San Juan
United States	Chu Eye Institute	Fort Worth	Texas
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Eye Surgeons of CNY	Liverpool	New York
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Wolstan & Goldberg Eye Associates	Torrance	California
United States	Tulsa Ophthalmology	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to Year 3
Primary	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)	Up to Year 3
Primary	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	Up to Year 3