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Набор скоро начнётся NCT07175324

Oct-A and Perimetry in Multiple Sclerosis

— Наблюдательное Multiple Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: optical coherence tomography angiography, Visual Field Perimetry.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Correlation Between Optical Coherence Tomography Angiography and Visual Field Changes in Patients With Multiple Sclerosis

Обзор

This study aims to assess retinal vascular density using OCT-A and correlate these parameters with visual field changes in MS patients with and without a history of ON

Подробное описание

The aim of this work is to investigate the correlation between visual field parameters and optical coherence tomography angiography (OCT-A) findings in patients with multiple sclerosis (MS). MS is a chronic autoimmune demyelinating disease that frequently involves the visual pathway, often presenting with optic neuritis (ON) and subsequent neurodegeneration. OCT-A, a non-invasive imaging modality, enables detailed visualization and quantification of retinal microvasculature, particularly the superficial and deep capillary plexuses, which supply the retinal ganglion cells and nerve fiber layers. Previous studies have demonstrated reduced retinal vessel density and thinning of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) in MS patients, reflecting neuro-axonal damage and microvascular impairment. However, the relationship between these structural and vascular changes and functional visual outcomes, such as visual field loss, remains to be fully elucidated.

This study aims to assess retinal vascular density using OCT-A and correlate these parameters with visual field indices in MS patients with and without a history of ON. By analyzing inter-eye differences and comparing with MS patients, the research seeks to clarify whether OCT-A metrics can serve as reliable biomarkers for visual dysfunction and disease progression in MS. Understanding this correlation could improve early detection of neuroretinal damage, guide monitoring of disease activity, and potentially inform therapeutic strategies.

Вмешательства

  • Устройство optical coherence tomography angiography
    correlation between OctA and Visual field changes in Multiple Sclerosis
  • Устройство Visual Field Perimetry
    Correlation between OctA and Visual field changes in Multiple sclerosis

Первичные конечные точки

  • 1-To evaluate the correlation between OCTA-derived microvascular metrics {Structural measure} and visual field defects{Functional measure} in patients with multiple sclerosis (MS) [Срок оценки: baseline]

Критерии участия

Критерии включения

  • Diagnosis of relapsing-remitting multiple sclerosis (RR-MS) or other MS subtypes confirmed by established neurological criteria. .Ability to undergo OCTA imaging and visual field testing. .Visual acuity sufficient to perform reliable visual field testing.
  • Absence of other ocular diseases affecting the retina or optic nerve (e.g., diabetic retinopathy, glaucoma)

Критерии исключения

.History of ocular diseases unrelated to MS that could confound OCTA or visual field results.

.Recent optic neuritis episode within a defined period (often 3-6 months) to avoid acute inflammation effects.

.Media opacities preventing quality OCTA imaging. .Systemic diseases that may affect retinal vasculature (e.g., uncontrolled hypertension, diabetes).

.Poor cooperation or inability to complete visual field testing reliably

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Mancino, R., Martucci, A., Di Costanzo, A., et al. (2021).Optical coherence tomography and optical coherence tomography angiography findings in multiple sclerosis patientshttps://www.tandfonline.com/doi/full/10.1080/01658107.2021.1963787
  • Liu J, Song S, Gu X, Li H, Yu X. Microvascular impairments detected by optical coherence tomography angiography in multiple sclerosis patients: A systematic review and meta-analysis. Front Neurosci. 2023 Jan 13;16:1121899. doi: 10.3389/fnins.2022.1121899. eCollection 2022. PMID 36711144
  • Farci R, Carta A, Cocco E, Frau J, Fossarello M, Diaz G. Optical coherence tomography angiography in multiple sclerosis: A cross-sectional study. PLoS One. 2020 Jul 23;15(7):e0236090. doi: 10.1371/journal.pone.0236090. eCollection 2020. PMID 32702050
  • Mohammadi S, Gouravani M, Salehi MA, Arevalo JF, Galetta SL, Harandi H, Frohman EM, Frohman TC, Saidha S, Sattarnezhad N, Paul F. Optical coherence tomography angiography measurements in multiple sclerosis: a systematic review and meta-analysis. J Neuroinflammation. 2023 Mar 27;20(1):85. doi: 10.1186/s12974-023-02763-4. PMID 36973708

Идентификаторы

NCT: NCT07175324 · OctA in Multiple sclerosis

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗