Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Age greater than 18 years.
Signed informed consent to study participation.
Willingness and ability to undergo all study visits and procedures.
Disqualifiers
Refusal to participate or withdrawal of informed consent.
Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion).
Inability to understand instructions given by investigators.
Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT
DeviceSpectral-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).
Treatment groups
1,050 Participants
are divided into 5 treatment groupsGroup A: Multiple Sclerosis patients1 intervention
Group B: Alzheimer's disease patients1 intervention
Group C: Parkinson's disease patients1 intervention
Group D: Migraine and headache patients1 intervention
Group E: Healthy Controls1 intervention
Trial outcomes
Primary outcomes
1
Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
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 months2
Annual rate of peripapillary RNFL thinning in patients with Alzheimer's Disease vs healthy controls
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 months3
Annual rate of peripapillary RNFL thinning in patients with Parkinson's Disease vs healthy controls
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 months4
Annual rate of macular GCL thinning in patients with Multiple Sclerosis disease vs healthy controls
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 monthsSecondary outcomes
1
Correlation between RNFL thinning rate and EDSS worsening in Multiple Sclerosis
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 months2
Correlation between GCL thinning rate and EDSS worsening in Multiple Sclerosis
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 months3
Correlation between IPL thinning rate and EDSS worsening in Multiple Sclerosis
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 months4
Correlation between RNFL thinning rate and UPDRS worsening in Parkinson's disease
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov