Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff

NCT02837562 | Withdrawn

• 1 other identifier: STU-042016-016
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

Radiation exposure; Cardiac catheterization

Outcome Measures

Primary Outcomes (1)

• Radiation associated lens opacities

  Measured by slit-lamp eye examination

  At study completion, approximately 30 minutes after administration of mydriatic eye drops

Study Arms (2)

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

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

Interventions

Slit lamp eye examination OTHER

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

Interventional Cardiology/Cath Lab Staff; Non-Interventional Cardiology/ Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Willing to undergo eye examination
• Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Dallas VA Research Corporation: collaborator

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Emmanouil S Brilakis, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 19, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share