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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02837562
Collaborator
Dallas VA Research Corporation (Industry)
0
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Study Details

Study Description

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 Phase
  • 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.

Study Design

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 1, 2016
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Radiation associated lens opacities [At study completion, approximately 30 minutes after administration of mydriatic eye drops]

    Measured by slit-lamp eye examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center
  • Dallas VA Research Corporation

Investigators

  • Principal Investigator: Emmanouil S Brilakis, MD, PhD, University of Texas Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02837562
Other Study ID Numbers:
  • STU-042016-016
First Posted:
Jul 19, 2016
Last Update Posted:
Jan 18, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Texas Southwestern Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2019