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Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff (IC-CATARACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837562
Recruitment Status : Withdrawn (0)
First Posted : July 19, 2016
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Dallas VA Research Corporation
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Cataract Other: Slit lamp eye examination

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff- CATaracts Attributed to Radiation in the CaTh Lab: The IC-CATARACT Study
Study Start Date : May 2016
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Interventional Cardiology/Cath Lab Staff

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
All participants in the trial will undergo a slit lamp eye examination

Non-Interventional Cardiology/ Controls

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
All participants in the trial will undergo a slit lamp eye examination




Primary Outcome Measures :
  1. Radiation associated lens opacities [ Time Frame: At study completion, approximately 30 minutes after administration of mydriatic eye drops ]
    Measured by slit-lamp eye examination



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants of the Society of Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, 2016
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837562


Sponsors and Collaborators
University of Texas Southwestern Medical Center
Dallas VA Research Corporation
Investigators
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Principal Investigator: Emmanouil S Brilakis, MD, PhD University of Texas Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02837562    
Other Study ID Numbers: STU-042016-016
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Texas Southwestern Medical Center:
Radiation exposure
Cardiac catheterization
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases