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CompletedNCT01061463Updated Apr 6, 2015

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

An observational study in Cataracts and Lens Opacities, sponsored by Sophie JACOB. Completed at 1 site in France. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-06.

Sponsored by Sophie JACOB · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
250
Ages
40 Years to 75 Years
Sex
All
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Study summary

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.

Read the 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).

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Conditions studied

  • Cataracts
  • Lens Opacities

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Keywords

  • Radiation cataracts
  • Lens opacities
  • X-rays
  • Interventional Cardiologists
  • Electrophysiologists
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In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 250 is above the median of 89 across 475 observational studies indexed under Cataract.

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Lead sponsor

Sophie JACOB is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • previous history of medical radiation exposure for radiotherapy or brain scans
  • for non-interventional cardiologists: occupational history of interventional cardiologist
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
250 participants (actual)

Groups and 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

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What researchers measure

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

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Study locations

1 site
  • IRSN
    Fontenay-aux-Roses, 92262, France
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References and documents

Publications

  • Jacob S, Michel M, Spaulding C, Boveda S, Bar O, Brezin 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. doi: 10.1186/1471-2458-10-537. PubMed 20825640 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01061463
Lead sponsor
Sophie JACOB
Responsible party
Sophie JACOB (PhD, Institut de Radioprotection et de Surete Nucleaire) — Sponsor-investigator
First posted
Feb 3, 2010
Start date
Oct 2009
Primary completion
Jan 2011
Completion
Mar 2011
Last update
Apr 6, 2015

Study contacts

Sophie JACOB, PhD.
principal investigator · Institut de Radioprotection et de Surete Nucleaire

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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