跳至主要内容
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2021年6月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Injury Brain
发起方
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
入组人数
75
试验地点
1
主要终点
Reading performance
状态
已完成
最后更新
3年前

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). Eye-tracking test: with an animation of a moving circle.

注册库
clinicaltrials.gov
开始日期
2021年6月1日
结束日期
2022年11月30日
最后更新
3年前
研究类型
Observational
性别
All

研究者

发起方
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
责任方
Sponsor

入排标准

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)

研究点 (1)

Loading locations...

相似试验