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

February 2, 2010
March 25, 2011
October 2009
January 2011   (final data collection date for primary outcome measure)
Lens opacities [ Time Frame: up to 1.5 year ] [ Designated as safety issue: No ]
Lens opacities [ Time Frame: October 2009 to January 2011 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01061463 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Nuclear, cortical or posterior subcapsular cataract [ Time Frame: October 2009 to January 2011 ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: October 2009 to January 2011 ] [ Designated as safety issue: No ]
  • Major eye disorders (glaucoma, etc…) [ Time Frame: October 2009 to January 2011 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study
Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists

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.

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).

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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

  • Cataracts
  • Lens Opacities
Not Provided
  • 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
Jacob S, Michel M, Spaulding C, Boveda S, Bar O, Brézin AP, Streho M, Maccia C, Scanff P, Laurier D, Bernier MO. Occupational cataracts and lens opacities in interventional cardiology (O'CLOC study): are X-Rays involved? Radiation-induced cataracts and lens opacities. BMC Public Health. 2010 Sep 8;10:537.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
March 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01061463
IRSN-09079
Yes
Sophie JACOB, PhD., Institut de Radioprotection et de Surete Nucleaire
Institut de Radioprotection et de Surete Nucleaire
Not Provided
Principal Investigator: Sophie JACOB, PhD. Institut de Radioprotection et de Surete Nucleaire
Institut de Radioprotection et de Surete Nucleaire
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP