跳至主要内容
临床试验/NCT04037384
NCT04037384Unknown不适用

Alternative Home Training Possibilities for Glaucoma Patients

University of Magdeburg4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8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
40
试验地点
4
主要终点
Visual field size determined by perimetry measurements

研究概览

简要总结

The aim of the trial is to investigate the possibilities of improving visual impairments with eye training exercises (eye-yoga) in a total of 40 patients with glaucoma who have not previously been treated within a similar training program. 20 patients will be instructed how to do eye yoga to be performed dails for 4 weeks (max 30 min/day). As a control group of 20 patients will be instructed to read for 30 min/day for 4 weeks.

The following outcome measures will be investigated: High Resolution Perimetry, Humphrey Perimetry, Visual Acuity Test, Contrast Sensitivity Test, Microsaccades measurements, Intraocular Pressure Measurement, Electroencephalogram (EEG), Blood Pressure and Pulse Measurement and Dynamic Vessel Analysis (DVA - the blood supply in the eye (especially vascular dysregulation) .

Furthermore, factors that could influence response variability and the effectiveness of treatment will be analysed: (i) the role of mental stress (or stress resilience) and (ii) the influence of personality traits and quality of life.

The study is intended to further validate this home training program (eye yoga) for the treatment of visual impairment in glaucoma.

详细描述

The aim of eye yoga is to improve microsaccade impairments in patient with primary open angle glaucoma. We will study how this affects visual performance and the physiology of the eye and brain

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of glaucoma
  • residual vision
  • the duration of the disease must be at least 6 months old
  • the visual field defect must be stable

排除标准

  • autoimmune diseases in the acute stage
  • neurological and mental diseases
  • diabetic retinopathy
  • addictions
  • hypertension (maximum 160/100 mmHg)
  • retinitis pigmentosa-
  • pathological nystagmus
  • non-distant tumors or recurrent tumors
  • photosensitivity
  • pregnancy

结局指标

主要结局

Visual field size determined by perimetry measurements

时间窗: 4 weeks

Changes of the visual field's size, evaluated by static perimetry and high resolution perimetry measurements

Microsaccade measurements

时间窗: 4 weeks

Changes in the deviation of eye movements when visual targets are followed, using a computerized test

次要结局

  • EEG connectivities(4 weeks)
  • Blood circulation in the eye(4 weeks)

研究者

发起方
University of Magdeburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernhard A. Sabel

Head of Institute, Professor

University of Magdeburg

研究点 (4)

Loading locations...

相似试验