Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study
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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 |
- Lens opacities [ Time Frame: up to 1.5 year ] [ Designated as safety issue: No ]
- 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 |
Interventional and non-interventional cardiologists from public and private French hospitals/facilities, both groups of cardiologists being matched for age and gender.
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| France | |
| IRSN | |
| Fontenay-aux-Roses, France, 92262 | |
| 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 May 19, 2013