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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Vivity IOL - Non Toric | Experimental | 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. |
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| Clareon Vivity IOL - Toric | Experimental | 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. |
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| Clareon PanOptix IOL - Non Toric | Experimental | 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. |
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| Clareon PanOptix IOL - Toric | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon Vivity IOL - Non Toric | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of Adverse Events | Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following:
| Up to Year 3 |
| Rate of Device Deficiencies | Device deficiencies will be assessed at each prospective visit. Examples include the following:
| Up to Year 3 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States | ||
| Levenson Eye Associates |
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| Clareon Vivity IOL - Toric | Device | 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. |
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| Clareon PanOptix Trifocal IOL - Non Toric | Device | 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. |
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| Clareon PanOptix Trifocal IOL - Toric | Device | 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. |
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| Jacksonville |
| Florida |
| 32204 |
| United States |
| Eye Surgeons of CNY | Liverpool | New York | 13088 | United States |
| Tulsa Ophthalmology | Tulsa | Oklahoma | 74104 | United States |
| Chu Eye Institute | Fort Worth | Texas | 76107 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| Centro Oftalmologico Metropolitano | San Juan | 00921 | Puerto Rico |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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