Aphakia, Astigmatism, Presbyopia
Conditions
Keywords
Cataract surgery
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 1 follow-up visit.
Interventions
DEVICEClareon 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.
DEVICEClareon 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.
DEVICEClareon 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.
DEVICEClareon 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
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit | Up to Year 3 | BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR). |
| Number of Adverse Events | Up to Year 3 | 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) |
| Number of Device Deficiencies | Up to Year 3 | 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 |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORClinical Trial Lead, Surgical
Alcon Research, LLC
Outcome results
None listed