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Not yet recruiting NCT07175324

Oct-A and Perimetry in Multiple Sclerosis

Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: optical coherence tomography angiography, Visual Field Perimetry.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

.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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07175324 · OctA in Multiple sclerosis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗