跳至主要内容
临床试验/NCT02837562
NCT02837562撤回不适用

Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff- CATaracts Attributed to Radiation in the CaTh Lab: The IC-CATARACT Study

University of Texas Southwestern Medical Center0 个研究点开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Radiation associated lens opacities

研究概览

简要总结

The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history.

The hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.

详细描述

This is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (PSC) and its association with prior occupational history of radiation exposure. Participants of the Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, will be invited to participate. Both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. Written informed consent will be obtained from all participants. They will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified Merriam-Focht scoring system.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Willing to undergo eye examination
  • Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions

排除标准

  • Known pre-existing severe eye disease, such as glaucoma
  • Prior lens surgery
  • Known hypersensitivity to the mydriatic agents
  • Any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of the investigator

结局指标

主要结局

Radiation associated lens opacities

时间窗: At study completion, approximately 30 minutes after administration of mydriatic eye drops

Measured by slit-lamp eye examination

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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