Measuring Blood Vessel Density in the Optic Nerve of Multiple Sclerosis Patients With OCTA

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:

1. Does MS change the blood flow in the optic nerve?
2. 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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Diagnostic test: Optical Coherence Tomography Angiography

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?

2. 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.

3. 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 Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Egypt
  • Faiyum Governorate
    • Al Fayyum, Faiyum Governorate, Egypt, 63514
      • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• group 1; patients with multiple sclerosis with optic neuritis.
• group 2; normal healthy age matched controls

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiple Sclerosis (MS) Cohort; 26 eyes of patients with clinically definite MS	Diagnostic test: Optical Coherence Tomography Angiography; 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.
Healthy Control Cohort; 28 eyes of age- and sex-matched normal subjects	Diagnostic test: Optical Coherence Tomography Angiography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RNFL thickness	Retinal Nerve Fiber Layer (RNFL) thickness, measured in micrometers, for the superior and inferior hemispheres of the optic nerve head.	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.	Baseline

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Actual): August 3, 2025
• Study Completion (Actual): August 3, 2025

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: R687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes