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

17 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

De observación

Inscripción (Estimado)

1050

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Roberto Santangelo, MD

Ubicaciones de estudio

  • Italia
    • Milano
      • Milan, Milano, Italia, 20132
        • Reclutamiento
        • IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit
        • Contacto:
        • Investigador principal:
          • Massimo Filippi, Prof, MD
        • Sub-Investigador:
          • Federica Agosta, MD
        • Sub-Investigador:
          • Roberto Santangelo, MD
        • Contacto:
          • Roberto Santangelo, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Dispositivo: 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.
Dispositivo: 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.
Dispositivo: 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.
Dispositivo: 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.
Dispositivo: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between RNFL thinning rate and EDSS worsening in Multiple Sclerosis
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

IRCCS San Raffaele

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de octubre de 2023

Finalización primaria (Estimado)

1 de abril de 2030

Finalización del estudio (Estimado)

1 de abril de 2031

Fechas de registro del estudio

Enviado por primera vez

17 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2026

Publicado por primera vez (Actual)

22 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • OCtINN

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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