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Completed

NCT Number: NCT04937725

Reading Problems Associated With Central Nervous System (CNS) Pathologies.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 .

Treatment and study plan

eye tracking

Diagnostic Test

Eye tracker will be used to evaluate study parameters

Primary outcomes

  1. Reading performance

    Time frame: 24 Hours

    International Reading Speed Texts (IReST)

Secondary outcomes

  1. Reading performance

    Time frame: 24 Hours

    DEM (Developmental Eye Movement).ocular (DEM)

Other outcomes

  1. Eye tracking

    Time frame: 24 Hours

    Eye-tracking test

Sponsors and collaborators

Lead sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Other

Collaborators

  • Hospital Clínico Universitario de Valladolid
  • Hospital del Rio Hortega

Registry information

Official study title

Reading Problems Associated With Central Nervous System Pathologies

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2021
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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