Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff

Withdrawn

• Conditions: Cataract
• Interventions: Other: Slit lamp eye examination

• Registration Number: NCT02837562
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history.

The hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.

Detailed Description

This is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (PSC) and its association with prior occupational history of radiation exposure. Participants of the Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, will be invited to participate. Both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. Written informed consent will be obtained from all participants. They will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified Merriam-Focht scoring system.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Willing to undergo eye examination
• Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions

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Exclusion Criteria

• Known pre-existing severe eye disease, such as glaucoma
• Prior lens surgery
• Known hypersensitivity to the mydriatic agents
• Any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of the investigator

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interventional Cardiology/Cath Lab Staff	Slit lamp eye examination	This is considered to be the "case" or group under study. These are Interventional Cardiology/ Cardiac Cath lab staff that are exposed to radiation as a result of their role as Cardiac Cath lab staff. Intervention: Slit lamp eye examination
Non-Interventional Cardiology/ Controls	Slit lamp eye examination	This is considered to be the "control" or comparison group. These are non-interventional cardiology/ non-cardiac cath lab staff that are not exposed to radiation as they do no operate/ work in the Cardiac Cath Lab. Intervention: Slit lamp eye examination

Primary Outcome Measures

Name	Time	Method
Radiation associated lens opacities	At study completion, approximately 30 minutes after administration of mydriatic eye drops	Measured by slit-lamp eye examination