A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for neurological patients:
- •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.
- •Inclusion Criteria for healthy controls:
- •Absence of neurological disease.
- •Age greater than 18 years.
- •Signed informed consent to study participation.
- •Willingness and ability to undergo all study visits and procedures.
排除标准
- •for neurological patients:
- •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.
- •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:
- •Refusal to participate or withdrawal of informed consent.
- •Known or confirmed ocular pathology identified during examination.
- •Inability to understand instructions given by investigators.
- •Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
结局指标
主要结局
Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
时间窗: 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.
Annual rate of peripapillary RNFL thinning in patients with Alzheimer's Disease vs healthy controls
时间窗: 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.
Annual rate of peripapillary RNFL thinning in patients with Parkinson's Disease vs healthy controls
时间窗: 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.
Annual rate of macular GCL thinning in patients with Multiple Sclerosis disease vs healthy controls
时间窗: 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
Annual rate of macular GCL thinning in patients with Alzheimer's Disease vs healthy controls
时间窗: 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
Annual rate of macular GCL thinning in patients with Parkinson's Disease vs healthy controls
时间窗: 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
Annual rate of macular IPL thinning in patients with Multiple Sclerosis vs healthy controls
时间窗: 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
Annual rate of macular IPL thinning in patients with Alzheimer's Disease vs healthy controls
时间窗: 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
Annual rate of macular IPL thinning in patients with Parkinson's Disease vs healthy controls
时间窗: 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
次要结局
- Correlation between RNFL thinning rate and EDSS worsening in Multiple Sclerosis(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thinning rate and EDSS worsening in Multiple Sclerosis(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thinning rate and EDSS worsening in Multiple Sclerosis(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thinning rate and UPDRS worsening in Parkinson's disease(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thinning rate and UPDRS worsening in Parkinson's disease(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thinning rate and neuropsychological performance in Alzheimer's disease(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thinning rate and neuropsychological performance in Alzheimer's disease(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thinning rate and neuropsychological performance in Alzheimer's disease(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thickness and brain MRI lesion load(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thickness and brain MRI cortical atrophy(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thickness and brain MRI lesion load(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thickness and brain MRI cortical atrophy(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thickness and brain MRI lesion load(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thickness and brain MRI cortical atrophy(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thickness and PET findings(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thickness and PET findings(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thickness and PET findings(Baseline, 6, 12, 18, and 24 months)
- 24. Correlation between RNFL thickness and CSF biomarker (Abeta40)(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thickness and CSF biomarker (Abeta40)(Baseline, 6, 12, 18, and 24 months)
- orrelation between IPL thickness and CSF biomarker (Abeta40)(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thickness and CSF biomarker (Abeta42)(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thickness and CSF biomarker (Abeta42)(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thickness and CSF biomarker (Abeta42)(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thickness and CSF biomarkers (pTAU)(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thickness and CSF biomarkers (pTAU)(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thickness and CSF biomarkers (pTAU)(Baseline, 6, 12, 18, and 24 months)
- Correlation between RNFL thickness and CSF biomarkers (NfL)(Baseline, 6, 12, 18, and 24 months)
- Correlation between GCL thickness and CSF biomarkers (NfL)(Baseline, 6, 12, 18, and 24 months)
- Correlation between IPL thickness and CSF biomarkers (NfL)(Baseline, 6, 12, 18, and 24 months)
研究者
Prof. Massimo Filippi
Prof, MD
IRCCS San Raffaele