跳至主要内容
临床试验/NCT02992262
NCT02992262Unknown不适用

Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination

michal roll0 个研究点目标入组 300 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.

研究概览

简要总结

Pediatric emergency department (PED) physicians frequently encounter children with symptoms that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP) such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED physician, is considered an essential modality for assessment of the optic disc and the diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient compliance, the ability to open the eyelids, the absence of opacities in the ocular media and a sufficiently large pupillary aperture. Hence, different levels of PED physician training, lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis and severe photophobia may hinder direct fundoscopic evaluation.

In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic examination. The investigators aim to evaluate the yield of optic disc height as measured with ocular point of care ultrasound to detect optic disc swelling in comparison to ophthalmologic examination as the gold standard.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Consecutive patients from the PED,
  • •Aged 0-18 years,
  • •Who require funduscopic examination and referred to ophthalmologic evaluation.

排除标准

  • •Direct trauma to the eye with suspicion of ruptured globe or laceration of the eyelid,
  • •History of glaucoma.

结局指标

主要结局

The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.

时间窗: Up to 24h from inclusion or until hospital discharge if admitted

次要结局

未报告次要终点

研究者

发起方
michal roll
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

michal roll

Director, Research and development unit, Tel-Aviv Medical Center, Israel

Tel-Aviv Sourasky Medical Center

相似试验