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临床试验/NCT03750149
NCT03750149Unknown不适用

Reading Analysis in Ophthalmologic Patients: a Pilot Study

Prim. Prof. Dr. Oliver Findl, MBA2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Reading speed

研究概览

简要总结

Investigation of the reading parameters and fixation behavior in patients with different ocular diseases (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal membrane) and healthy subjects. In addition, fixation analysis and retinal sensitivity measurements will be done with a microperimeter in each subject.

详细描述

Reading is a complex function. It requires a proper retinal image that is received by the brain. There it is analyzed for letter and word recognition and then the semantics is detected. Reading speed slows down when letters are blurred, or do not have enough contrast or luminance or when binocular fusion is hampered. Hence, it is obvious that reading ability is reduced in patients with various ocular diseases. Especially, pathologies effecting the posterior pole (central and paracentral vision) might impair reading parameters significantly.

Recently, the Eyetracker Eyelink 1000 (SR Research Ltd, Canada) became available. It´s application was described previously. Briefly, a high-speed infrared camera detects the position of eye (pupil and corneal reflex) and in turn the direction of gaze 500 times per second. During the calibration process the position can be linked to the position on a screen where, for instance, a text or a fixation target can be projected. Direction of gaze is recorded during the reading process and the gathered data are analyzed.

Fixation ability was assessed using Eyelink 1000 in patients with age-related macular degeneration. It was shown that fixation is related to visual function. The worse eye showed reduced fixation ability which is improved during binocular fixation. This study investigates reading parameters in patients with various ocular diseases.

研究设计

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

入排标准

年龄范围
21 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 and older
  • Absence of ocular disease (Group 1)
  • Present ocular disease (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal membrane/macular hole) as judged by the investigator (Group 2 - 5)
  • Maximum of allowed cylinder-power in the spectacles: +1.50D

排除标准

  • Ocular pathologies, that may interfere with study measurements, such as corneal scars
  • In case of pregnancy (pregnancy test will be taken prior to inclusion into the study in women of reproductive age)

研究组 & 干预措施

Ophthalmologic Disease

Experimental

Patients with glaucoma, AMD, diabetic maculopathy, epiretinal membranes, and healthy patients will undergo a reading analysis using the EyeTracker

干预措施: EyeTracker (Device)

结局指标

主要结局

Reading speed

时间窗: 12 months

Reading speed (words per minute) will be analysed using the EyeTracker device. The patient has to read 4 texts with different contrast levels. The faster the patient can read a text, the better the results.

次要结局

  • Retinal perimetry(12 months)

研究者

发起方
Prim. Prof. Dr. Oliver Findl, MBA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (2)

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