Clareon IOL Retrospective Data Collection

Completed

• Conditions: Astigmatism; Aphakia
• Interventions: Device: Clareon UVA IOL; Device: WaveTec Optiwave Refractive Analysis (ORA) System; Procedure: Cataract surgery

• Registration Number: NCT05796674
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-03
• Study Start: 2023-08-18
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1090

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Alcon Research, LLC; 🇺🇸 Fort Worth, Texas, United States