Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05706220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-16
First Post:
2022-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Organization:
Study Overview
Official Title:
Visual Processing Speed and Objective Analysis of Supranuclear Ocular Movements Control in Multiple Sclerosis Patients and Its Relationship With OCT and Reading Difficulties
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to analyze ocular motility problems, visual processing speed and microperimetry, and their relationship with consolidated retinal structural biomarkers (optical coherence tomography, OCT) in patients with Multiple Sclerosis w/w reading complaints comparing with healthy subjects.
Detailed Description:
Anamnesis, ophthalmological medical history including difficulties in reading with appropriate glasses.
The following protocol will be applied:
* Comprehensive eye examination
* Stereopsis
* Primary gaze position
* Cover test: far and near
* Vergence and version eye movements
* Presence of nystagmus
* Far and near best corrected visual acuity, with updated refraction
-.Pupillary light reflex
* Biomicroscopy of the anterior pole
* Intraocular pressure
* Recording of eye movements during two standardized tests: International Reading Speed Texts test (IReST®) and Developmental Eye Movement Test (DEM™) with Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software.
* Visual processing speed
* Microperimetry
* Optical coherence tomography
* Eye fundus
* Patients with a history of clinical optic neuritis will additionally undergo contrast sensitivity tests, the Farnsworth® test (Farnsworth test 28 Hue x 100) and normal monocular perimetry using the standard Swedish Interactive Thresholding Algorithm (SITA-central 24-2) perimeter test. Humphrey® (Humphrey visual field analyser) and other tests at the discretion of the investigator.
The following protocol will be applied:
* Comprehensive eye examination
* Stereopsis
* Primary gaze position
* Cover test: far and near
* Vergence and version eye movements
* Presence of nystagmus
* Far and near best corrected visual acuity, with updated refraction
-.Pupillary light reflex
* Biomicroscopy of the anterior pole
* Intraocular pressure
* Recording of eye movements during two standardized tests: International Reading Speed Texts test (IReST®) and Developmental Eye Movement Test (DEM™) with Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software.
* Visual processing speed
* Microperimetry
* Optical coherence tomography
* Eye fundus
* Patients with a history of clinical optic neuritis will additionally undergo contrast sensitivity tests, the Farnsworth® test (Farnsworth test 28 Hue x 100) and normal monocular perimetry using the standard Swedish Interactive Thresholding Algorithm (SITA-central 24-2) perimeter test. Humphrey® (Humphrey visual field analyser) and other tests at the discretion of the investigator.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: