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临床试验/NCT03286426
NCT03286426终止不适用

Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure

Duke University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Changes in Posterior Segment as Measured by Fundus Camera

研究概览

简要总结

The purpose of this study is to evaluate the vision and posterior segment of eyes in children and young adults less than 22 years of age with risk, suspicion, or past medical history significant for elevated intracranial pressure (ICP). Patients will have visual acuity and color vision tested. Assessment of the posterior segment will involve using a non-invasive (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital settings).

详细描述

The need for non-invasive evaluation of ICP is an active area of study. The current gold standard is intraventricular or intraparenchymal catheters but these are invasive, expensive, and require sedation; and thus the need for an effective non-invasive screening tool. The utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e. papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated that funduscopy may have a role in the qualitative assessment of increased ICP as a highly sensitive test. However, conventional bedside funduscopy does not allow for image capture and may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency Department).

Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline), retinol, and isotretinol, are at particular risk for increased ICP but often are not identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of patients with subclinical asymptomatic disease is unclear. This study would allow us to describe the presence of subclinical disease in our population and the role/utility of routine non-invasive screening methods.

研究设计

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

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Capable and willing to provide consent
  • Less than 22 years of age
  • History of or suspicion for elevated ICP or starting/currently taking high-risk medications associated with increased risk for elevated ICP

排除标准

  • Unable or unwilling to give consent
  • Over 21 years of age

结局指标

主要结局

Changes in Posterior Segment as Measured by Fundus Camera

时间窗: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent

Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)

时间窗: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent

Changes in Visual Acuity

时间窗: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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