Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff

Cataract Clinical Trial

— IC-CATARACT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02837562
• Other study ID #: STU-042016-016
• Status: Withdrawn
• Start date: May 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• Slit lamp eye examination
All participants in the trial will undergo a slit lamp eye examination

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Dallas VA Research Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation associated lens opacities	Measured by slit-lamp eye examination	At study completion, approximately 30 minutes after administration of mydriatic eye drops