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临床试验/NCT03596138
NCT03596138已完成不适用

Reliability and Reproducibility of Automated Angular Measurement in Strabismus

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Intra-class correlation coefficient

研究概览

简要总结

Angular measurement of deviation is an essential element in the clinical evaluation of strabic patients. It is performed by orthoptic methods. However, studies show that the same patient presents a great variability of his angular measurement between 2 consultations, and between 2 observers.

Automated angle measurement is a recent concept that aims to overcome the defects of subjective angle measurement by alternate occlusion test and prismatic bar.

Improvements made by these devices would provide reliable, objective and reproducible measurements of the angle of deviation by increasing the accuracy of strabal angle assessment, improving decision making and surgical follow-up, decreasing inter-examiner variability and variability over time, and facilitating data comparison to improve scientific publication possibilities.

The Gazelab® device is a video-oculograph combined with a laser projection system and an infrared camera. It allows an objective angular evaluation, in non-dissociating physiological conditions, possible even in the absence of binocular vision and allows an analysis of the deviation in all positions.

There is extremely little data in the literature on automated measuring devices. The Gazelab tool is still little known in the strabology discipline and seems to have a number of advantages over other devices. The interest of this examination towards this pathology led the ophthalmology department to use it in the current practice, and since recently it is an act nomenclaturé.

详细描述

The objective of this work is to evaluate the reliability and reproducibility of the automated angular measurement by the Gazelab® (ES12/13127) apparatus, compared to the standard gold which is the angular measurement by alternate occlusion test and prismatic bar, in horizontal strabisms (converging and diverging). Indeed in our daily practice the 2 examinations are carried out. To compare with the standard gold which denotes a strong inter-observer variability, the investigator will compare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) 2 times with 2 trained examiners

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Patients over 18 years of age
  • Strabic convergent or divergent patients or patients requiring an oculomotor check-up in their follow-up consultation
  • Patient giving oral consent to this study

排除标准

  • Patient with medical follow-up impossible,
  • Impossibility to install Gazelab equipment for anatomical reasons of the head (craniostenosis...)
  • No ocular fixation.
  • Major without freedom under guardianship or trusteeship

结局指标

主要结局

Intra-class correlation coefficient

时间窗: 12 months

Intra-class correlation coefficient calculated on the 4 measures (2 of each technique) of each patient taken at time 1 by the same assessor.

次要结局

  • Intra-class correlation coefficient using measurements(12 months)
  • Intraclass correlation coefficient using time 1 and time 2 measurements(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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