Multiple SclerosisNCT07629804
Measuring Blood Vessel Density in the Optic Nerve of Multiple Sclerosis Patients With OCTA
An observational study of Multiple Sclerosis, run by Fayoum University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the effect of multiple sclerosis on the blood flow of the optic nerve of affected patients compared to normal subjects by OCTA. The main question it aims to answer is: 1. Does MS change the blood flow in the optic nerve? 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Optical Coherence Tomography Angiography
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2025to 3 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This case-control study enrolled two groups: group 1; 26 adults with a clinically definite diagnosis of Multiple Sclerosis (Cases) and group 2; 28 age- and sex-matched healthy adults with no history of neurological or significant ocular disease (Controls).
Who may be able to join
- group 1; patients with multiple sclerosis with optic neuritis.
- group 2; normal healthy age matched controls
Who cannot join
- Other optic nerve diseases as glaucoma, papilledema or conginetal anomalies.
- Other macular diseases as AMD, CSR, scars …
- Errors of refraction outside +4 and -6 D range.
- Media opacity as cataracts or corneal opacities that may interfere with the quality of scans.
- Signal strength index less than 4\10.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative OCT Angiography Differences in Optic Nerve Vascular Density in Multiple Sclerosis: A Case-Control Study
The goal of this observational study is to learn about the effect of multiple sclerosis on the blood flow of the optic nerve of affected patients compared to normal subjects by OCTA. The main question it aims to answer is:
- Does MS change the blood flow in the optic nerve?
- If it does, can measuring this blood flow be used as a simple sign (a biomarker) to help doctors understand and manage MS?
Read more
We used a quick and painless eye scan called Optical Coherence Tomography Angiography (OCTA). This special scan takes detailed pictures of the blood vessels in the optic nerve without needing any injections. We performed this scan on two groups of people: one group with MS and one group without MS, and then compare the results.
In simple terms, why is this important? If we can show that MS affects the optic nerve blood vessels, it could give us a new, quick way to monitor the disease and see how it is progressing, just by doing a simple eye scan.
Read the detailed description
The optic nerve is like the main cable that carries visual information from the eye to the brain. In Multiple Sclerosis (MS), the body's immune system mistakenly attacks the protective covering (called myelin) around nerve fibers, including those in the optic nerve. This often causes a condition called optic neuritis, which can lead to vision loss.
While we know MS damages the nerve fibers, we are now trying to understand how it affects the blood vessels that supply oxygen and nutrients to the optic nerve. Are these blood vessels damaged as well? Does reduced blood flow contribute to the nerve damage?
- The Technology We Are Using
This study uses a advanced, non-invasive imaging technology called Optical Coherence Tomography Angiography (OCTA).
What it does: The OCTA machine uses a safe, dim light beam to scan the optic nerve and macula. It works like a microscopic radar for blood vessels, allowing us to create very detailed, high-resolution 3D maps of the blood flow in the retina and optic nerve without any needles or injections.
What we measure: From these maps, we can quantitatively analyze the vessel density which is a percentage that tells us how much of a specific area is filled with functioning blood vessels. We will focus this measurement on the Radial Peripapillary Capillaries, which are the blood vessels that directly supply the optic nerve head.
- The Purpose and Potential Impact of This Research
The main goal of this study is to determine if the blood vessel density in the optic nerve is a reliable biological marker (or biomarker) for MS.
A biomarker is an objective, measurable sign of a medical condition. If we can prove that changes in optic nerve blood flow are a consistent marker of MS, it could provide us with:
A new tool to help understand the disease activity in an individual.
A quick and painless way to potentially monitor how the disease is changing over time and whether treatments are effectively protecting the nervous system.
By comparing these detailed OCTA measurements between participants with and without MS, we hope to better understand the role of blood flow in the disease and contribute to improved future care for people living with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Optical Coherence Tomography Angiography
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDiagnostic test
optic nerve head analysis as regards the vessel density and retinal nerve fiber layer thickness and ganglion cell complex analysis as regards thickness and focal loss volume and global loss volume.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis (MS) Cohort | 26 eyes of patients with clinically definite MS Receives: Diagnostic Test: Optical Coherence Tomography Angiography | |
| Healthy Control Cohort | 28 eyes of age- and sex-matched normal subjects Receives: Diagnostic Test: Optical Coherence Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
vessel density of the optic nerve head and peripapillary region measured by OCTA
Difference in microvascular vessel density, as measured by Optical Coherence Tomography Angiography (OCTA), in the optic nerve head and peripapillary region between patients with Multiple Sclerosis and healthy controls. Analysis will include the whole disc area, inside the disc, and individual quadrants.
Measured: Baseline
Secondary outcomes (2)
RNFL thickness
Retinal Nerve Fiber Layer (RNFL) thickness, measured in micrometers, for the superior and inferior hemispheres of the optic nerve head.
Measured: Baseline
GCC thickness
The thickness of the macular Ganglion Cell Complex (GCC) was measured in micrometers for the superior and inferior hemispheres. These measurements were then analyzed by the device's proprietary software to calculate the Focal Loss Volume (FLV) and Global Loss Volume (GLV) indices.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start5 Jan 2025
- Primary completion3 Aug 2025
- Study completion3 Aug 2025
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.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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
- 54 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Abdul Fattah Saad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629804
- Sponsor's protocol ID
- R687
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative OCT Angiography Differences in Optic Nerve Vascular Density in Multiple Sclerosis: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07629804
- Acronym / sponsor ID
- R687
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 3 Aug 2025 (actual)
- Study completion
- 3 Aug 2025 (actual)
- First posted
- 5 Jun 2026 (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.
The goal of this observational study is to learn about the effect of multiple sclerosis on the blood flow of the optic nerve of affected patients compared to normal subjects by OCTA. The main question it aims to answer is:
- Does MS change the blood flow in the optic nerve?
- If it does, can measuring this blood flow be used as a simple sign (a biomarker) to help doctors understand and manage MS?
We used a quick and painless eye scan called Optical Coherence Tomography Angiography (OCTA). This special scan takes detailed pictures of the blood vessels in the optic nerve without needing any injections. We performed this scan on two groups of people: one group with MS and one group without MS, and then compare the results.
In simple terms, why is this important? If we can show that MS affects the optic nerve blood vessels, it could give us a new, quick way to monitor the disease and see how it is progressing, just by doing a simple eye scan.
Detailed description
The optic nerve is like the main cable that carries visual information from the eye to the brain. In Multiple Sclerosis (MS), the body's immune system mistakenly attacks the protective covering (called myelin) around nerve fibers, including those in the optic nerve. This often causes a condition called optic neuritis, which can lead to vision loss.
While we know MS damages the nerve fibers, we are now trying to understand how it affects the blood vessels that supply oxygen and nutrients to the optic nerve. Are these blood vessels damaged as well? Does reduced blood flow contribute to the nerve damage?
- The Technology We Are Using
This study uses a advanced, non-invasive imaging technology called Optical Coherence Tomography Angiography (OCTA).
What it does: The OCTA machine uses a safe, dim light beam to scan the optic nerve and macula. It works like a microscopic radar for blood vessels, allowing us to create very detailed, high-resolution 3D maps of the blood flow in the retina and optic nerve without any needles or injections.
What we measure: From these maps, we can quantitatively analyze the vessel density which is a percentage that tells us how much of a specific area is filled with functioning blood vessels. We will focus this measurement on the Radial Peripapillary Capillaries, which are the blood vessels that directly supply the optic nerve head.
- The Purpose and Potential Impact of This Research
The main goal of this study is to determine if the blood vessel density in the optic nerve is a reliable biological marker (or biomarker) for MS.
A biomarker is an objective, measurable sign of a medical condition. If we can prove that changes in optic nerve blood flow are a consistent marker of MS, it could provide us with:
A new tool to help understand the disease activity in an individual.
A quick and painless way to potentially monitor how the disease is changing over time and whether treatments are effectively protecting the nervous system.
By comparing these detailed OCTA measurements between participants with and without MS, we hope to better understand the role of blood flow in the disease and contribute to improved future care for people living with MS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (MS) Cohort | – | Diagnostic Test: Optical Coherence Tomography Angiography26 eyes of patients with clinically definite MS |
| Healthy Control Cohort | – | Diagnostic Test: Optical Coherence Tomography Angiography28 eyes of age- and sex-matched normal subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This case-control study enrolled two groups: group 1; 26 adults with a clinically definite diagnosis of Multiple Sclerosis (Cases) and group 2; 28 age- and sex-matched healthy adults with no history of neurological or significant ocular disease (Controls).
Key inclusion criteria (2 listed)
- group 1; patients with multiple sclerosis with optic neuritis.
- group 2; normal healthy age matched controls
Key exclusion criteria (5 listed)
- Other optic nerve diseases as glaucoma, papilledema or conginetal anomalies.
- Other macular diseases as AMD, CSR, scars …
- Errors of refraction outside +4 and -6 D range.
- Media opacity as cataracts or corneal opacities that may interfere with the quality of scans.
- Signal strength index less than 4\10.
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 |
|---|---|---|
| Optical Coherence Tomography Angiographyoptic nerve head analysis as regards the vessel density and retinal nerve fiber layer thickness and ganglion cell complex analysis as regards thickness and focal loss volume and global loss volume. | Diagnostic test | Healthy Control Cohort, Multiple Sclerosis (MS) Cohort |
Primary outcome
vessel density of the optic nerve head and peripapillary region measured by OCTA
Time frame: Baseline
Difference in microvascular vessel density, as measured by Optical Coherence Tomography Angiography (OCTA), in the optic nerve head and peripapillary region between patients with Multiple Sclerosis and healthy controls. Analysis will include the whole disc area, inside the disc, and individual quadrants.
2 secondary outcomes
RNFL thickness
Time frame: Baseline
GCC thickness
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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, run by Fayoum University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 5 Jun 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
vessel density of the optic nerve head and peripapillary region measured by OCTA (time frame: Baseline). 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 5 Jun 2026.