NCT05796674

Clareon IOL Retrospective Data Collection

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,090 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aphakia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Clareon 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.
DEVICE	WaveTec 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
PROCEDURE	Cataract surgery	Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL

Timeline

• Start date: 2023-08-18
• Primary completion: 2023-09-12
• Completion: 2023-09-12
• First posted: 2023-04-03
• Last updated: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study