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

NCT07629804 | Completed FDA Device

• 1 other identifier: R687
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does MS change the blood flow in the optic nerve?
2. 2.If it does, can measuring this blood flow be used as a simple sign (a biomarker) to help doctors understand and manage MS?

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• RNFL thickness

  Baseline

• GCC thickness

  Baseline

Study Arms (2)

Multiple Sclerosis (MS) Cohort

26 eyes of patients with clinically definite MS

Diagnostic Test: Optical Coherence Tomography Angiography

Healthy Control Cohort

28 eyes of age- and sex-matched normal subjects

Diagnostic Test: Optical Coherence Tomography Angiography

Interventions

Optical Coherence Tomography Angiography DIAGNOSTIC_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.

Healthy Control Cohort; Multiple Sclerosis (MS) Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum university Hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of ophthalmology - Faculty of medicine - Fayoum university

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: June 5, 2026
• Study Start: January 5, 2025
• Primary Completion: August 3, 2025
• Study Completion: August 3, 2025
• Last Updated: June 5, 2026

Record last verified: 2025-09

Locations

EG (1)