- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07720765
Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N) (OCT)
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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Federica Agosta, MD
- 전화번호: 0226433051
- 이메일: agosta.federica@hsr.it
연구 연락처 백업
- 이름: Roberto Santangelo, MD
연구 장소
-
-
Milano
-
Milan, Milano, 이탈리아, 20132
- 모병
- IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit
-
연락하다:
- Federica Agosta, MD
- 전화번호: 0226433051
- 이메일: agosta.federica@hsr.it
-
수석 연구원:
- Massimo Filippi, Prof, MD
-
부수사관:
- Federica Agosta, MD
-
부수사관:
- Roberto Santangelo, MD
-
연락하다:
- Roberto Santangelo, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria 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.
Exclusion Criteria 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
|
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.
|
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.
|
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.
|
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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation between RNFL thinning rate and EDSS worsening in Multiple Sclerosis
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Massimo Filippi, Prof, MD, IRCCS San Raffaele
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OCtINN
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .