Trials / Active Not Recruiting
Active Not RecruitingNCT05796453
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 470 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-09-19
- Primary completion
- 2028-06-01
- Completion
- 2028-06-01
- First posted
- 2023-04-03
- Last updated
- 2025-08-14
Locations
7 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05796453. Inclusion in this directory is not an endorsement.