An observational study in Aphakia and Astigmatism, sponsored by Alcon Research. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Alcon Research (part of Alcon) · Observational
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.
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 1,090 is above the median of 95 across 15 observational studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).
Information is entered into the WaveTec AnalyzOR Database by medical professionals post cataract surgery.
Data Selection Criteria (eyes):
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 · Device: WaveTec Optiwave Refractive Analysis (ORA) System · Procedure: Cataract surgery
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.
Also known as: Models CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, CCA0T0
Intra-operative system used during refractive cataract surgery to capture wavefront images of the patient's eye for the purpose of optimizing IOL implantation
Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL
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.
Time frame: Month 1 postoperative
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Sep 2023, 0 months.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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