NCT Number: NCT07720765
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milan, Milano, 20132, Italy
Location status: Recruiting
Federica Agosta, MD
CONTACT
Federica Agosta, MD
SUB_INVESTIGATOR
Massimo Filippi, Prof, MD
PRINCIPAL_INVESTIGATOR
Roberto Santangelo, MD
CONTACT
Roberto Santangelo, MD
SUB_INVESTIGATOR
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for neurological patients:
Inclusion criteria
for healthy controls:
Exclusion criteria
for neurological patients:
Exclusion criteria
for healthy controls:
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
IRCCS San Raffaele
Other
A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice
Acronym: OCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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