Clareon IOL Retrospective Data Collection

Alcon

Status: Completed

Conditions: Astigmatism; Aphakia

Treatments: Device: Clareon UVA IOL; Device: WaveTec Optiwave Refractive Analysis (ORA) System; Procedure: Cataract surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05796674

ILS241-R001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,090 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,090 participants in 1 patient group

Clareon UVA IOL

Description:

Eyes that underwent cataract surgery and received a Clareon UVA IOL with the use of the WaveTec Optiwave Refractive Analysis (ORA) System

Treatment:

Procedure: Cataract surgery

Device: WaveTec Optiwave Refractive Analysis (ORA) System

Device: Clareon UVA IOL