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CompletedNCT04937725Updated Feb 2, 2023

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

An observational study in Injury Brain, Eye Abnormalities and Multiple Sclerosis, sponsored by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Injury Brain
  • Eye Abnormalities
  • Multiple Sclerosis
  • Parkinson Disease
  • Ataxia, Cerebellar

Keywords

  • eye tracking
03

In context

Brain Injuries

946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.

This study's enrollment of 75 is below the median of 100 across 302 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Normal population (no pathology) and people with neurological pathologies such as multiple sclerosis, Parkinson, tumours, or stroke, cerebellum ataxia and other miscellaneous neurological disorders.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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: (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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients without neurological pathologies

    Patients with no history of neurological diseases

    Diagnostic Test: eye tracking

  • Patients with neurological pathologies

    Diagnostic Test: eye tracking

Interventions

  • Diagnostic testeye tracking

    Eye tracker will be used to evaluate study parameters

06

What researchers measure

Primary outcomes

  1. Reading performance

    International Reading Speed Texts (IReST)

    Time frame: 24 Hours

Secondary outcomes

  1. Reading performance

    DEM (Developmental Eye Movement).ocular (DEM)

    Time frame: 24 Hours

Other outcomes

  1. Eye tracking

    Eye-tracking test

    Time frame: 24 Hours

07

Study locations

1 site
  • IOBA - Universidad de Valladolid
    Valladolid, 47011, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04937725
Lead sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
Hospital Clínico Universitario de Valladolid, Hospital del Rio Hortega
Responsible party
Sponsor
First posted
Jun 24, 2021
Start date
Jun 1, 2021
Primary completion
Nov 1, 2022
Completion
Nov 30, 2022
Last update
Feb 2, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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