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NCT05796674 Clinical Trial

Clareon IOL Retrospective Data Collection

Astigmatism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05796674
Other study ID # ILS241-R001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 18, 2023
Est. completion date September 12, 2023

Study information
Verified date October 2023
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1090
Est. completion date September 12, 2023
Est. primary completion date September 12, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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

Locations
Country Name City State
United States Alcon Research, LLC Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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