Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study

This study has been completed.
Sponsor:
Information provided by:
Institut de Radioprotection et de Surete Nucleaire
ClinicalTrials.gov Identifier:
NCT01061463
First received: February 2, 2010
Last updated: March 25, 2011
Last verified: February 2010
  Purpose

The purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to X-rays.


Condition
Cataracts
Lens Opacities

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists

Resource links provided by NLM:


Further study details as provided by Institut de Radioprotection et de Surete Nucleaire:

Primary Outcome Measures:
  • Lens opacities [ Time Frame: up to 1.5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: up to 1.5 year ] [ Designated as safety issue: No ]
  • Major eye disorders (glaucoma, etc…) [ Time Frame: up to 1.5 year ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposed group
French coronary interventional cardiologists and cardiologists specializing in cardiac arrhythmias treatments (electrophysiologists), occupationally exposed to X-Rays
Unexposed group
French non-interventional cardiologists and non medical workers, not occupationally exposed to X-Rays

Detailed Description:

This cross-sectional study includes cardiologists aged > 40 years: a group of interventional cardiologists (coronary interventionists and electrophysiologists) and a group of unexposed workers (including cardiologists). Individual information, including risk factors of cataracts (age, diabetes, myopia, etc. ...), are collected during a telephone interview. For the exposed group, a specific section of the questionnaire is focused on the occupational history, the description of the procedures (type, frequency, radiation protection tool) and will be used for the classification into "comparable exposure level" groups according to estimates of cumulative dose. For all participants, eye examinations are performed to specifically detect cataracts even in the early stages (lens opacities, LOCS III according to the international standard classification).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Interventional and non-interventional cardiologists from public and private French hospitals/facilities, both groups of cardiologists being matched for age and gender.

Criteria

Inclusion Criteria:

  • aged at least 40 yrs old
  • for interventional cardiologists: cumulated number of procedures > 2000

Exclusion Criteria:

  • previous history of medical radiation exposure for radiotherapy or brain scans
  • for non-interventional cardiologists: occupational history of interventional cardiologist
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061463

Locations
France
IRSN
Fontenay-aux-Roses, France, 92262
Sponsors and Collaborators
Institut de Radioprotection et de Surete Nucleaire
Investigators
Principal Investigator: Sophie JACOB, PhD. Institut de Radioprotection et de Surete Nucleaire
  More Information

No publications provided by Institut de Radioprotection et de Surete Nucleaire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sophie JACOB, PhD., Institut de Radioprotection et de Surete Nucleaire
ClinicalTrials.gov Identifier: NCT01061463     History of Changes
Other Study ID Numbers: IRSN-09079
Study First Received: February 2, 2010
Last Updated: March 25, 2011
Health Authority: France: French Data Protection Authority

Keywords provided by Institut de Radioprotection et de Surete Nucleaire:
Radiation cataracts
Lens opacities
X-rays
Interventional Cardiologists
Electrophysiologists

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014