跳至主要内容
临床试验/NCT02631369
NCT02631369已完成不适用

Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs Using the Integrated Algorithm by Heidelberg Spectralis

University of Zurich2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2015年12月最近更新:
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
82
试验地点
2
主要终点
study: excyclotorsion in degrees on SLO-fundus fotographs

研究概览

简要总结

Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of the influence of measuring with or without eye tracker.

Study: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg Spectralis

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
None

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

  • ≥ 18 years old
  • best corrected visual acuity ≥ 0.8

排除标准

  • strabismus except for forth nerve palsy
  • previous strabismus surgery
  • best corrected visual acuity ≤ 0.6
  • hyperopia or myopia > 6dpt

研究组 & 干预措施

inter- & intrarater reliability study

Experimental

pre-study: inter- and intrarater reliability study in 30 healthy subjects, interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device

干预措施: Heidelberg Spectralis OCT device (Device)

cyclotorsion in forth nerve palsy

Experimental

measurement of cyclotorsion on SLO-fundusphoto in 20 patients forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device

干预措施: Heidelberg Spectralis OCT device (Device)

cyclotorsion in healthy subjects

Experimental

measurement of cyclotorsion on SLO-fundusphoto in 30 healthy subjects to be compared to patients with forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device

干预措施: Heidelberg Spectralis OCT device (Device)

结局指标

主要结局

study: excyclotorsion in degrees on SLO-fundus fotographs

时间窗: 12 months

study: comparison of cyclotorsion measurements in healthy controls compared to patients with forth nerve palsy; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis

pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs

时间窗: 3 months

pre-study: inter- and intrarater reliability of the device with or without eye tracker; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis

次要结局

  • study: excyclotorsion in degrees on tangent screen, double maddox and fundus photographs(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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