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临床试验/NCT03119311
NCT03119311已完成不适用

A Novel Diagnostic Method for Exotropia Using Video-oculography

Inje University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
The angle of ocular deviation (degree,°) measured by VOG and PCT

研究概览

简要总结

Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared the value obtained using VOG and the angle of a rotating model eye, and subsequently made a new linear equation using these data. The calculated values obtained using VOG were compared with those obtained using APCT to determine the diagnostic accuracy of VOG.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

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

入选标准

  • have horizontal strabismus, cooperative, visual acuity >= 1.0/1.0

排除标准

  • have vertical strabimus> 5prism diopter, not cooperative, no agree

研究组 & 干预措施

VOG group

Experimental

Video-oculography

干预措施: Video-oculography (Diagnostic Test)

APCT group

Active Comparator

alternative prism cover test

干预措施: APCT (Diagnostic Test)

结局指标

主要结局

The angle of ocular deviation (degree,°) measured by VOG and PCT

时间窗: 2 weeks after approval

strabismic angle (degree,°) measured by VOG and PCT

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung-Hyuk Moon

professor

Inje University

研究点 (1)

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