Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff

Study Overview
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Brief Summary
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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
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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.

Official Title
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Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff- CATaracts Attributed to Radiation in the CaTh Lab: The IC-CATARACT Study

Conditions
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Cataract

Intervention / Treatment
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* Other: Slit lamp eye examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to undergo eye examination Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interventional Cardiology/Cath Lab Staff<br>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 | Other: Slit lamp eye examination<br>* All participants in the trial will undergo a slit lamp eye examination<br>|
| Non-Interventional Cardiology/ Controls<br>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 | Other: Slit lamp eye examination<br>* All participants in the trial will undergo a slit lamp eye examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation associated lens opacities | Measured by slit-lamp eye examination | At study completion, approximately 30 minutes after administration of mydriatic eye drops | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation exposure, Cardiac catheterization