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

January 16, 2019 updated by: University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Dallas VA Research Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (ESTIMATE)

July 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-042016-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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