Clinical Trials Logo
  1. Home
  2. Cataracts
  3. NCT01061463
  4. Details
NCT01061463 Clinical Trial

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

Cataracts Clinical Trial

Official title:
Study of the Occupational Risk of Radiation-induced Cataracts Among Cardiologists

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01061463
Other study ID # IRSN-09079
Secondary ID
Status Completed
Phase N/A
First received February 2, 2010
Last updated April 3, 2015
Start date October 2009
Est. completion date March 2011

Study information
Verified date April 2015
Source Institut de Radioprotection et de Surete Nucleaire
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection Authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date March 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
France IRSN Fontenay-aux-Roses

Sponsors (1)
Lead Sponsor Collaborator
Sophie JACOB

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lens opacities up to 1.5 year No
Secondary Visual acuity up to 1.5 year No
Secondary Major eye disorders (glaucoma, etc…) up to 1.5 year No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06005675 - User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
Active, not recruiting NCT01382641 - Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery Phase 4
Completed NCT01382823 - Laser Cataract Surgery With the Femtosecond Laser Technology Phase 4
Completed NCT05991960 - Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Active, not recruiting NCT05574959 - Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V N/A
Completed NCT02492659 - Clinical Research of Femtosecond Laser-Assisted Cataract Surgery N/A
Completed NCT01279031 - Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial Phase 4
Completed NCT00999492 - Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront Phase 4
Completed NCT01001806 - A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification Phase 4
Completed NCT01021761 - A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification Phase 4
Completed NCT00542581 - Acrysof Toric SN60T3corneal Astigmatism Between 0.75 and 1.00 D. N/A
Completed NCT03708367 - A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice N/A
Completed NCT05575063 - Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) N/A
Recruiting NCT05531292 - PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002 N/A
Completed NCT05058274 - Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
Completed NCT05053399 - Evaluation of the TECNIS Symfony® Toric Intraocular Lens N/A
Recruiting NCT02639845 - Eye Drop Application Monitor, Pilot Study N/A
Completed NCT01684007 - A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients N/A
Completed NCT00827073 - Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery N/A
Completed NCT00405730 - Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo Phase 3