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:
- 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Faiyum Governorate
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Al Fayyum, Faiyum Governorate, Egipto, 63514
- Fayoum University hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Multiple Sclerosis (MS) Cohort
26 eyes of patients with clinically definite MS
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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.
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Healthy Control Cohort
28 eyes of age- and sex-matched normal subjects
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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vessel density of the optic nerve head and peripapillary region measured by OCTA
Periodo de tiempo: Baseline
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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.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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RNFL thickness
Periodo de tiempo: Baseline
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Retinal Nerve Fiber Layer (RNFL) thickness, measured in micrometers, for the superior and inferior hemispheres of the optic nerve head.
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Baseline
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GCC thickness
Periodo de tiempo: Baseline
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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.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R687
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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