Aphakia, Astigmatism
Conditions
Brief summary
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
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.
Interventions
DEVICEClareon UVA IOL
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.
DEVICEWaveTec Optiwave Refractive Analysis (ORA) System
Intra-operative system used during refractive cataract surgery to capture wavefront images of the patient's eye for the purpose of optimizing IOL implantation
PROCEDURECataract surgery
Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit | Month 1 postoperative | 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. |
Countries
United States
Outcome results
None listed