NCT01061463

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

February 2, 2010

Last Update Submit

April 3, 2015

Conditions

CataractsLens Opacities

Keywords

Radiation cataractsLens opacitiesX-raysInterventional CardiologistsElectrophysiologists

Outcome Measures

Primary Outcomes (1)

  • Lens opacities

    up to 1.5 year

Secondary Outcomes (2)

  • Visual acuity

    up to 1.5 year

  • Major eye disorders (glaucoma, etc…)

    up to 1.5 year

Study Arms (2)

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

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRSN

Fontenay-aux-Roses, 92262, France

Location

Related Publications (1)

  • 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.

    PMID: 20825640DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Sophie JACOB, PhD.

    Institut de Radioprotection et de Surete Nucleaire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 3, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

FR(1)