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Completed

NCT Number: NCT01061463

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

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.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases Lens Opacities

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRSN

Fontenay-aux-Roses, 92262, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lens opacities

    Time frame: up to 1.5 year

Secondary outcomes

  1. Visual acuity

    Time frame: up to 1.5 year

  2. Major eye disorders (glaucoma, etc…)

    Time frame: up to 1.5 year

Sponsors and collaborators

Lead sponsor

Sophie JACOB

Other Gov

Registry information

Official study title

Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 3, 2010
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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