Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon UVA IOL | Eyes that underwent cataract surgery and received a Clareon UVA IOL with the use of the WaveTec Optiwave Refractive Analysis (ORA) System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon UVA IOL | Device | 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. |
| 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 |
Not provided
Not provided
Data Selection Criteria (eyes):
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Research, LLC | Fort Worth | Texas | 76134 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
Not provided
Not provided
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| WaveTec Optiwave Refractive Analysis (ORA) System | Device | 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 surgery | Procedure | Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL |
|
| D013514 | Surgical Procedures, Operative |