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临床试验/NCT04937725
NCT04937725已完成不适用

Reading Problems Associated With Central Nervous System Pathologies

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Reading performance

研究概览

简要总结

This project aims to analyse eye movements, their alterations and influence in reading performance in patients with acquired CNS diseases and compare them with people of the same age, without neurological or ocular pathology and with normal reading speed and pattern.

The exploration is focused on the oculomotor system in patients with CNS diseases, even without involvement of the primary visual pathway, and reveals more involvement than the one obtained by a simple ophthalmological examination.

详细描述

The following protocol will be applied:

Neuropsychological function Clock Test- Clock Drawing, whose score corresponds to a scale of 1 to 6, from perfect organization to severe disorder respectively, with a cognitive deficit being a result greater than 3. This test is used to detect signs of heminegligence in addition to the Line Bisection Test. It will consider the displacement of the central mark to the right side as a positive sign.

Mini-Cognitive Exam, whose cut-off score corresponds to 23 out of the 30 total, equal to or less than this figure, would indicate the presence of a cognitive deficit.

Far and near Best corrected visual acuity Primary gaze position Cover test (far and near) Extrinsic ocular motility Nystagmus presence Intrinsic ocular motility Biomicroscopy of the anterior pole Computerized visual field 30-2 Intraocular pressure Ocular fundus examination Records with Tobii Pro Nano Hardware Package eye-tracking system and Tobii Pro Lab - Full Edition software.

Reading performance assessment: International Reading Speed Texts (IReST) Attentional questionnaire based on the IReST, two simple answer questions (one word) will be formulated for each text, at the end of the reading to check the reading comprehension of the patient Evaluation of the speed and quality of horizontal and vertical reading: Test DEM (Developmental Eye Movement).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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
是

入选标准

  • •Patients and normal volunteers with ages between 18 and 80 years old.
  • •Clinical radiological neurological stability in acute CNS diseases (≥ 3 months after ACD).
  • •Best distant binocular visual acuity, equal or greater than 0.5 (Decimal Scale). Best close binocular visual acuity, equal or greater than 20/40.Glasses or soft contact lenses users.

排除标准

  • •Presence of visual heminegligence evaluated with clock drawing test and line bisection test.
  • •Presence of visual agnosia: Poppelreuter-Ghent © test.
  • •Presence of cognitive deficit: mini mental state examination (MMSE), with sufficient residual hearing capacity.
  • •Medical history, or presence after ophthalmic examination of: maculopathy, advanced cataracts, ophthalmological diseases affecting central visual acuity or macular fixation.
  • •Healthy control subjects should have normal monocular perimetry using standard Swedish interactive threshold algorithm (SITA) Central 30-2 Humphrey® Perimeter Test .

结局指标

主要结局

Reading performance

时间窗: 24 Hours

International Reading Speed Texts (IReST)

次要结局

  • Reading performance(24 Hours)

研究者

发起方
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
申办方类型
Other
责任方
Sponsor

研究点 (1)

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