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Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N) (OCT)

17 juillet 2026 mis à jour par: Prof. Massimo Filippi, IRCCS San Raffaele

A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice

OCt.IN.N is a national, monocentric, prospective, observational cohort study evaluating the utility and applicability of Optical Coherence Tomography (OCT) in the diagnostic workup and longitudinal monitoring of neurological diseases.

840 patients with Central Nervous System neurological diseases (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease, migraine/headache) and 210 age-matched healthy controls will undergo OCT examination at baseline and at 6, 12, 18, and 24 months of follow-up at IRCCS San Raffaele Hospital, Milan, Italy.

OCT is a non-invasive, rapid, and reproducible technique that automatically measures the thickness of individual retinal layers. Retinal layer thicknesses and their longitudinal changes will be correlated with established clinical scales, neuroimaging, and biological markers used in routine neurological practice.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

The retina and optic nerve share the same embryological origins as the central nervous system (CNS). Several neurological diseases - including Multiple Sclerosis (MS), Parkinson's disease (PD), and Alzheimer's disease (AD) - involve the visual system at both pre-chiasmatic (neuro-retina, optic nerve) and post-chiasmatic levels (optic tracts, optic radiations, primary visual cortex).

In MS, optic neuritis is one of the most frequent manifestations and can lead to optic nerve damage with retinal nerve fiber degeneration. In neurodegenerative diseases such as AD and PD, degeneration of retinal ganglion cells has been demonstrated. In AD, longitudinal observational studies have shown accelerated RNFL thinning over time compared to age-matched healthy controls, suggesting that neuro-retinal thinning in neurodegeneration reflects underlying neurodegenerative processes independent of normal aging.

Spectral-domain Optical Coherence Tomography (OCT) is a non-invasive, highly reproducible technique providing automated, high-resolution information on the thickness of individual retinal layers, including the retinal nerve fiber layer (RNFL), the ganglion cell layer (GCL), and the inner plexiform layer (IPL). OCT could represent a reliable, reproducible, and economically accessible tool for the diagnostic workup and monitoring of neurological diseases.

The device used is the Heidelberg SPECTRALIS HRA+OCT (Class IIa CE-marked medical device), operated according to the manufacturer's instructions and indications for use. The device is used according to its approved clinical indication for visualization of the posterior segment of the eye and retinal anatomy measurement.

Study design: monocentric, prospective, observational cohort study. Patients are recruited from the neurology outpatient clinics and inpatient wards of IRCCS San Raffaele Hospital. OCT is performed at baseline (T0) and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be requested at the investigators' discretion to exclude concurrent ocular pathology.

Three age subgroups are analyzed for all disease groups and controls: 20-40 years, 40-60 years, and over 60 years.

Statistical analyses include: descriptive statistics and ANOVA models (or non-parametric tests) for between-group comparisons at baseline; linear mixed-effects models for longitudinal changes over time; generalized estimating equations (GEE) when data from both eyes are considered; Pearson or Spearman correlation analyses between OCT measures and clinical, neuroimaging, and biological markers (EDSS for MS; UPDRS for PD; neuropsychological battery for AD; brain MRI, PET, and CSF biomarkers for migraine/headache).

Type d'étude

Observationnel

Inscription (Estimé)

1050

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Roberto Santangelo, MD

Lieux d'étude

  • Italie
    • Milano
      • Milan, Milano, Italie, 20132
        • Recrutement
        • IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit
        • Contact:
        • Chercheur principal:
          • Massimo Filippi, Prof, MD
        • Sous-enquêteur:
          • Federica Agosta, MD
        • Sous-enquêteur:
          • Roberto Santangelo, MD
        • Contact:
          • Roberto Santangelo, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients with a diagnosis of a Central Nervous System neurological disease (Multiple Sclerosis; Alzheimer's disease; Parkinson's disease; migraine/headache) recruited from the neurology outpatient clinics and inpatient wards of IRCCS San Raffaele Hospital, Milan, Italy. Healthy controls recruited primarily from medical students, colleagues, and relatives of patients.

La description

Inclusion Criteria for neurological patients:

  1. Diagnosis of a Central Nervous System neurological disease (inflammatory diseases such as Multiple Sclerosis; neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease; migraine/headache) according to currently accepted diagnostic criteria for each condition.
  2. Age greater than 18 years.
  3. Signed informed consent to study participation.
  4. Willingness and ability to undergo all study visits and procedures.

Inclusion Criteria for healthy controls:

  1. Absence of neurological disease.
  2. Age greater than 18 years.
  3. Signed informed consent to study participation.
  4. Willingness and ability to undergo all study visits and procedures.

Exclusion Criteria for neurological patients:

  1. Refusal to participate or withdrawal of informed consent.
  2. Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion).
  3. Inability to understand instructions given by investigators.
  4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
  5. For specific imaging modes using clearly visible light sources (MultiColor, FA, BAF): diagnosis of epilepsy or history of previous epileptic seizures.

Exclusion Criteria for healthy controls:

  1. Refusal to participate or withdrawal of informed consent.
  2. Known or confirmed ocular pathology identified during examination.
  3. Inability to understand instructions given by investigators.
  4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Multiple Sclerosis patients
210 patients with a diagnosis of Multiple Sclerosis according to current diagnostic criteria, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Undergo OCT at baseline and follow-up visits at 6, 12, 18, and/or 24 months, alongside standard clinical assessments including EDSS.
Dispositif: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Alzheimer's disease patients
210 patients with a diagnosis of Alzheimer's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard neuropsychological assessments, brain MRI, PET, and CSF biomarkers as part of routine clinical care.
Dispositif: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Parkinson's disease patients
210 patients with a diagnosis of Parkinson's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments including UPDRS.
Dispositif: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Migraine and headache patients
210 patients with a diagnosis of migraine or headache according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments.
Dispositif: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Healthy Controls
210 healthy subjects without neurological disease, age-matched to patients, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Recruited primarily from medical students, colleagues, and relatives of patients. Undergo OCT at baseline and follow-up visits.
Dispositif: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls.
Baseline, 6, 12, 18, and 24 months
Annual rate of peripapillary RNFL thinning in patients with Alzheimer's Disease vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls.
Baseline, 6, 12, 18, and 24 months
Annual rate of peripapillary RNFL thinning in patients with Parkinson's Disease vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls.
Baseline, 6, 12, 18, and 24 months
Annual rate of macular GCL thinning in patients with Multiple Sclerosis disease vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular GCL thinning in patients with Alzheimer's Disease vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular GCL thinning in patients with Parkinson's Disease vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular IPL thinning in patients with Multiple Sclerosis vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular IPL thinning in patients with Alzheimer's Disease vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular IPL thinning in patients with Parkinson's Disease vs healthy controls
Délai: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation between RNFL thinning rate and EDSS worsening in Multiple Sclerosis
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized RNFL thinning rate measured by OCT and worsening on the Expanded Disability Status Scale (EDSS) in patients with Multiple Sclerosis.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thinning rate and EDSS worsening in Multiple Sclerosis
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized GCL thinning rate measured by OCT and worsening on the Expanded Disability Status Scale (EDSS) in patients with Multiple Sclerosis.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thinning rate and EDSS worsening in Multiple Sclerosis
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized IPL thinning rate measured by OCT and worsening on the Expanded Disability Status Scale (EDSS) in patients with Multiple Sclerosis.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thinning rate and UPDRS worsening in Parkinson's disease
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized RNFL thinning rate measured by OCT and worsening on the Unified Parkinson's Disease Rating Scale (UPDRS) in patients with Parkinson's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thinning rate and UPDRS worsening in Parkinson's disease
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized GCL thinning rate measured by OCT and worsening on the Unified Parkinson's Disease Rating Scale (UPDRS) in patients with Parkinson's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thinning rate and neuropsychological performance in Alzheimer's disease
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized RNFL thinning rate measured by OCT and scores on comprehensive neuropsychological assessment in patients with Alzheimer's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thinning rate and neuropsychological performance in Alzheimer's disease
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized GCL thinning rate measured by OCT and scores on comprehensive neuropsychological assessment in patients with Alzheimer's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thinning rate and neuropsychological performance in Alzheimer's disease
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized IPL thinning rate measured by OCT and scores on comprehensive neuropsychological assessment in patients with Alzheimer's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and brain MRI lesion load
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL tickness and brain MRI parameters (lesion load) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and brain MRI cortical atrophy
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL tickness and brain MRI parameters (cortical atrophy) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and brain MRI lesion load
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL tickness and brain MRI parameters (lesion load) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and brain MRI cortical atrophy
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL tickness and brain MRI parameters (cortical atrophy) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and brain MRI lesion load
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL tickness and brain MRI parameters (lesion load) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and brain MRI cortical atrophy
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL tickness and brain MRI parameters (cortical atrophy) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and PET findings
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and brain PET parameters used in routine clinical practice for applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and PET findings
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and brain PET parameters used in routine clinical practice for applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and PET findings
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and brain PET parameters used in routine clinical practice for applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
24. Correlation between RNFL thickness and CSF biomarker (Abeta40)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (Abeta40) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarker (Abeta40)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (Abeta40) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
orrelation between IPL thickness and CSF biomarker (Abeta40)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (Abeta40) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and CSF biomarker (Abeta42)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (Abeta42) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarker (Abeta42)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (Abeta42) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and CSF biomarker (Abeta42)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (Abeta42) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and CSF biomarkers (pTAU)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (pTAU) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarkers (pTAU)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (pTAU) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and CSF biomarkers (pTAU)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (pTAU) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and CSF biomarkers (NfL)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (NfL) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarkers (NfL)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (NfL) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and CSF biomarkers (NfL)
Délai: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (NfL) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

IRCCS San Raffaele

Les enquêteurs

  • Chercheur principal: Massimo Filippi, Prof, MD, IRCCS San Raffaele

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 octobre 2023

Achèvement primaire (Estimé)

1 avril 2030

Achèvement de l'étude (Estimé)

1 avril 2031

Dates d'inscription aux études

Première soumission

17 juillet 2026

Première soumission répondant aux critères de contrôle qualité

17 juillet 2026

Première publication (Réel)

22 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OCtINN

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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