Multiple SclerosisNCT05706220
Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Eye tracking, Microperimetry and Optical coherence tomography (OCT)
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Control group (healthy volonteers) and patients with Multiple Sclerosis
Who may be able to join
- Diagnosis of Multiple Sclerosis
- Best distant corrected visual acuity equal or greater than 0.7 (decimal scale). Glasses or soft contact lenses users.
- Best close corrected visual acuity equal to or greater than 20/30 (Snellen scale).Glasses or soft contact lenses users.
Who cannot join
- Patients with a history of acute optic neuritis (ON) and/or who experienced an episode of ON <6 months prior to the study, to avoid potential interference of papilledema with accurate peripapillary RNFL thickness measurements.
- Patients with other retinal and optic nerve diseases, advanced cataracts according to the international Lens Opacities Classification System III (LOCS III) (opacities greater than C2N2)
- Patients with other ophthalmological diseases that could affect central visual acuity
- Subjects with high refractive error (+ - 6 diopters).
- Subjects with other demyelinating disorders (neuromyelitis optica or acute disseminated encephalomyelitis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis
- Being tested
- Eye tracking, Microperimetry, Optical coherence tomography (OCT), Visual processing speed test
- Keywords
- ocular motility disorders, eye movement, eye tracking, microperimetry, fixational eye movements, visual processing speed, optical coherence tomography
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye trackingDiagnostic test
Also called Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software
Eye tracker will be used to evaluate eye movements
MicroperimetryDiagnostic test
Also called Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test
Optical coherence tomography (OCT)Diagnostic test
Also called Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA
Macular Cube 512x128 or 200x200 scan. OCT will be used to analysis of retinal nerve fiber layer, ganglion cell complex and ganglion-cell/inner plexiform layer
Visual processing speed testDiagnostic test
Visual processing speed test will be used for assessing subject visual stimulus search and reach times.
Thirty-two different everyday visual stimuli divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities.
| Study group | Role | What they receive |
|---|---|---|
| Control group | * Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy)
* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software
* Visual processing speed
* Microperimetry
* Optical coherence tomography Receives: Diagnostic Test: Eye tracking; Diagnostic Test: Microperimetry; Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Visual processing speed test | |
| Clinically Isolated Syndrome Patients | * Ophthalmologic examination
* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software
* Visual processing speed
* Microperimetry
* Optical coherence tomography
* Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest) Receives: Diagnostic Test: Eye tracking; Diagnostic Test: Microperimetry; Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Visual processing speed test | |
| Relapsing-remitting Multiple Sclerosis Patients | * Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy)
* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software
* Visual processing speed
* Microperimetry
* Optical coherence tomography
* Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest) Receives: Diagnostic Test: Eye tracking; Diagnostic Test: Microperimetry; Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Visual processing speed test | |
| Primary Progressive Multiple Sclerosis Patients | * Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy)
* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software
* Visual processing speed
* Microperimetry
* Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest)
* Optical coherence tomography Receives: Diagnostic Test: Eye tracking; Diagnostic Test: Microperimetry; Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Visual processing speed test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Tracking Data
Characteristics of eye movements recorded with the eye tracker system during reading tests
Measured: 24 Hours
Values for Visual Processing Speed (VPS)
VPS will be assessing subject visual stimulus search reaction time (S-RT) and reach reaction time (R-RT), measured in seconds. Thirty-two different everyday visual stimuli were divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities (10º, 20º y 30º)
Measured: 24 Hours
Retinal sensitivity assessed by microperimetry
Sensitivity and fixation analysis with microperimetry
Measured: 24 Hours
Values for OCT neuroretinal and peripapillary parameters
OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans
Measured: 24 Hours
Secondary outcomes (9)
Fixations recorded with the eye tracker system
number of fixations, duration in milliseconds
Measured: 24 Hours
Saccades recorded with the eye tracker system
number of saccades, duration in milliseconds
Measured: 24 Hours
Fixation assessment with microperimetry
Fixation assessment: P1, P2 fixation points (indexes P1 and P2)
Measured: 24 Hours
Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry
BCEA assessment: areas BCEA 63, BCEA 95
Measured: 24 Hours
Preferred Retinal Locus (PRL) analysis with microperimetry
PRL assessment: Low-PRL, PRL High
Measured: 24 Hours
Analysis of the macular integrity (MI) with microperimetry
MI assessment: macular integrity index
Measured: 24 Hours
Ganglion Cell Layer measurement (GCL: Macular OCT)
Optical Coherence Tomography (OCT) will be used to assess the GCL of patients with multiple sclerosis
Measured: 24 Hours
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
Optical Coherence Tomography (OCT) will be used to assess the RNFL of patients with multiple sclerosis
Measured: 24 Hours
Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)
Optical Coherence Tomography (OCT) will be used to assess the GCIPL of patients with multiple sclerosis
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start13 Jun 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Eugenio Rodríguez Pascual, Hospital del Rio Hortega
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706220
- Sponsor's protocol ID
- 22-PI045
- Status last verified
- May 2025
- First submitted
- 28 Nov 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05706220
- Acronym / sponsor ID
- 22-PI045
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis
- Keywords
- ocular motility disorders, eye movement, eye tracking, microperimetry, fixational eye movements, visual processing speed, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- Fundación Eugenio Rodríguez Pascual, Hospital del Rio Hortega
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Eye tracking, Diagnostic Test: Microperimetry, Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Visual processing speed test* Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy) * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Optical coherence tomography |
| Clinically Isolated Syndrome Patients | – | Diagnostic Test: Eye tracking, Diagnostic Test: Microperimetry, Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Visual processing speed test* Ophthalmologic examination * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Optical coherence tomography * Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest) |
| Relapsing-remitting Multiple Sclerosis Patients | – | Diagnostic Test: Eye tracking, Diagnostic Test: Microperimetry, Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Visual processing speed test* Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy) * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Optical coherence tomography * Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest) |
| Primary Progressive Multiple Sclerosis Patients | – | Diagnostic Test: Eye tracking, Diagnostic Test: Microperimetry, Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Visual processing speed test* Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy) * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest) * Optical coherence tomography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Control group (healthy volonteers) and patients with Multiple Sclerosis
Key inclusion criteria (3 listed)
- Diagnosis of Multiple Sclerosis
- Best distant corrected visual acuity equal or greater than 0.7 (decimal scale). Glasses or soft contact lenses users.
- Best close corrected visual acuity equal to or greater than 20/30 (Snellen scale).Glasses or soft contact lenses users.
Key exclusion criteria (5 listed)
- Patients with a history of acute optic neuritis (ON) and/or who experienced an episode of ON <6 months prior to the study, to avoid potential interference of papilledema with accurate peripapillary RNFL thickness measurements.
- Patients with other retinal and optic nerve diseases, advanced cataracts according to the international Lens Opacities Classification System III (LOCS III) (opacities greater than C2N2)
- Patients with other ophthalmological diseases that could affect central visual acuity
- Subjects with high refractive error (+ - 6 diopters).
- Subjects with other demyelinating disorders (neuromyelitis optica or acute disseminated encephalomyelitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye trackingAlso: Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition softwareEye tracker will be used to evaluate eye movements | Diagnostic test | Clinically Isolated Syndrome Patients, Control group, Primary Progressive Multiple Sclerosis Patients, Relapsing-remitting Multiple Sclerosis Patients |
| MicroperimetryAlso: Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test | Diagnostic test | Clinically Isolated Syndrome Patients, Control group, Primary Progressive Multiple Sclerosis Patients, Relapsing-remitting Multiple Sclerosis Patients |
| Optical coherence tomography (OCT)Also: Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USAMacular Cube 512x128 or 200x200 scan. OCT will be used to analysis of retinal nerve fiber layer, ganglion cell complex and ganglion-cell/inner plexiform layer | Diagnostic test | Clinically Isolated Syndrome Patients, Control group, Primary Progressive Multiple Sclerosis Patients, Relapsing-remitting Multiple Sclerosis Patients |
| Visual processing speed testVisual processing speed test will be used for assessing subject visual stimulus search and reach times. Thirty-two different everyday visual stimuli divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities. | Diagnostic test | Clinically Isolated Syndrome Patients, Control group, Primary Progressive Multiple Sclerosis Patients, Relapsing-remitting Multiple Sclerosis Patients |
Primary outcome
Eye Tracking Data
Time frame: 24 Hours
Characteristics of eye movements recorded with the eye tracker system during reading tests
Values for Visual Processing Speed (VPS)
Time frame: 24 Hours
VPS will be assessing subject visual stimulus search reaction time (S-RT) and reach reaction time (R-RT), measured in seconds. Thirty-two different everyday visual stimuli were divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities (10º, 20º y 30º)
Retinal sensitivity assessed by microperimetry
Time frame: 24 Hours
Sensitivity and fixation analysis with microperimetry
Values for OCT neuroretinal and peripapillary parameters
Time frame: 24 Hours
OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans
9 secondary outcomes
Fixations recorded with the eye tracker system
Time frame: 24 Hours
Saccades recorded with the eye tracker system
Time frame: 24 Hours
Fixation assessment with microperimetry
Time frame: 24 Hours
Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry
Time frame: 24 Hours
Preferred Retinal Locus (PRL) analysis with microperimetry
Time frame: 24 Hours
Analysis of the macular integrity (MI) with microperimetry
Time frame: 24 Hours
Ganglion Cell Layer measurement (GCL: Macular OCT)
Time frame: 24 Hours
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
Time frame: 24 Hours
Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)
Time frame: 24 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Tracking Data (time frame: 24 Hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.