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

N/AActive Not RecruitingNCT05796453

Alcon Research470 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

470

Conditions

Aphakia Astigmatism Presbyopia

Interventions

Clareon Vivity IOL - Non ToricDEVICE

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 - ToricDEVICE

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 ToricDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Wolstan & Goldberg Eye Associates

Torrance, California, United States

Levenson Eye Associates

Jacksonville, Florida, United States

Eye Surgeons of CNY

Liverpool, New York, United States

Tulsa Ophthalmology

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

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).

Time frame: Up to Year 3

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)

Time frame: Up to Year 3

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

Time frame: Up to Year 3

Data from ClinicalTrials.gov

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