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
1 other identifier
observational
1,090
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2023
CompletedOctober 18, 2023
October 1, 2023
25 days
March 20, 2023
October 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Interventions
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.
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 extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL
Eligibility Criteria
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Research, LLC
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Lead, Surgical
Alcon Research, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2023
First Posted
April 3, 2023
Study Start
August 18, 2023
Primary Completion
September 12, 2023
Study Completion
September 12, 2023
Last Updated
October 18, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share