Clareon IOL Retrospective Data Collection

Study Overview
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Brief Summary
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The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.

Detailed Description
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In this retrospective postmarket study, the WaveTec AnalyzOR Database will be reviewed. All available data that meet the data selection criteria as of the data cutoff will be analyzed.

Official Title
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Post Market Clinical Follow-up (PMCF) Pilot Study for the Clareon UVA IOLs Using Retrospective Data Collection From the WaveTec AnalyzOR Database

Conditions
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Aphakia, Astigmatism

Intervention / Treatment
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* Device: Clareon UVA IOL
* Device: WaveTec Optiwave Refractive Analysis (ORA) System
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Data Selection Criteria (eyes): Must have undergone cataract extraction by phacoemulsification with implantation of a Clareon UVA IOL (CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, or CCA0T0) using the WaveTec ORA System. Must have a BCDVA in the WaveTec AnalyzOR Database from ≥ 10 days after surgery. Predicted residual refractive error spherical equivalent (SE) ≤ 0.75 D.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clareon UVA IOL<br>Eyes that underwent cataract surgery and received a Clareon UVA IOL with the use of the WaveTec Optiwave Refractive Analysis (ORA) System | Device: Clareon UVA IOL<br>* Clareon UVA IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery to replace the natural crystalline lens. Models CC60WF and CCA0T0 are indicated for the visual correction of aphakia. Models CCW0T3, CCW0T4, CCW0T5, and CCW0T6 are indicated for the visual correction of aphakia and preexisting corneal astigmatism.<br>* Other names: Models CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, CCA0T0;Device: WaveTec Optiwave Refractive Analysis (ORA) System<br>* Intra-operative system used during refractive cataract surgery to capture wavefront images of the patient's eye for the purpose of optimizing IOL implantation<br>Procedure: Cataract surgery<br>* Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit | The database will be reviewed for assessments of monocular (by-eye) best corrected distance visual acuity at the first postoperative visit. The first postoperative visit will be defined as the visit which occurred approximately 28 days or later from the operative visit during which time the IOL remained implanted in the eye and an eye exam was performed. | Month 1 postoperative |