Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Flicker induced increase in retinal blood flow
研究概览
简要总结
Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects twice as many women as men. MS is traditionally diagnosed by the presentation of lesions of the central nervous system, disseminated in time and in space, proven by clinical examination and magnetic resonance imaging. Several anatomical parameters in the eye, both vascular and neural, have been found to be altered in MS patients.
Because of its unique optical properties, the eye offers the possibility of the non-invasive assessment of both structural and functional alterations in neuronal tissue. As the neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative changes in the brain are accompanied by structural and possibly also functional changes in the neuro-retina and the ocular vasculature.
The current study seeks to test the hypothesis that beside the known anatomical changes, also functional changes can be detected in the retina of patients with MS. For this purpose, flicker light induced hyperemia will be measured in the retina as a functional test to assess the coupling between neural activity and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness and function parameters such as ocular blood flow and retinal oxygenation will be assessed and compared to age and sex matched controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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 healthy subjects:
- •Men and women aged over 18 years
- •Non-smokers
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, ametropy < 6 Dpt.
- •Inclusion criteria for patients with MS:
- •Men and women aged over 18 years
- •Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to clinical evaluation and McDonald criteria (revision 2010)
- •History of AON in one eye at least one year ago
- •Non-smokers
- •Normal ophthalmic findings, ametropy < 6 Dpt.
- •Adequate visual acuity to allow participation in the ocular blood flow measurements
- •A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except MS therapy itself which will be recorded separately) for at least 30 days prior inclusion, if considered relevant by the investigator.
- •Any of the following will exclude a healthy subject from the study:
- •Diagnosis of "possible MS" according to the McDonald criteria (revision 2010)
- •Presence or history of a severe medical condition as judged by the clinical investigator
- •Untreated Arterial hypertension
- •History or family history of epilepsy
- •Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- •Family history of MS, optic neuritis, neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders
- •History of inflammatory or infectious disease of central nervous system
- •Best corrected visual acuity < 0.5 Snellen
- •Ametropy ≥ 6Dpt
- •Pregnancy or planned pregnancy
- •Alcoholism or substance abuse
- •Any of the following will exclude a patient from the study:
- •Presence or history of a severe medical condition other than MS as judged by the clinical investigator
- •History of neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders
- •History of inflammatory or infectious disease of central nervous system other than MS
- •Untreated Arterial hypertension
- •History or family history of epilepsy
- •Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- •Best corrected visual acuity < 0.5 Snellen
- •Ametropy ≥ 6 Dpt
- •Pregnancy, planned pregnancy
- •Significant neurological disease other than MS, if considered relevant by the investigator
- •Alcoholism or substance abuse
排除标准
- 未提供
研究组 & 干预措施
Patients with MS
Patients with Multiple Sclerosis
干预措施: Dynamic Vessel Analyzer (DVA) (Device)
Patients with MS
Patients with Multiple Sclerosis
干预措施: Fourier Domain Doppler Optical Coherence Tomography (FDOCT) (Device)
Patients with MS
Patients with Multiple Sclerosis
干预措施: Optical coherence tomography (OCT) (Device)
Patients with MS
Patients with Multiple Sclerosis
干预措施: Optical coherence tomography angiography (OCTA) (Device)
Healthy control subjects
Healthy age- and sex- matched control subjects
干预措施: Dynamic Vessel Analyzer (DVA) (Device)
Healthy control subjects
Healthy age- and sex- matched control subjects
干预措施: Fourier Domain Doppler Optical Coherence Tomography (FDOCT) (Device)
Healthy control subjects
Healthy age- and sex- matched control subjects
干预措施: Optical coherence tomography (OCT) (Device)
Healthy control subjects
Healthy age- and sex- matched control subjects
干预措施: Optical coherence tomography angiography (OCTA) (Device)
结局指标
主要结局
Flicker induced increase in retinal blood flow
时间窗: 1 day
Response of retinal blood flow to flicker light assessed with FDOCT
次要结局
- Layer specific flow signal(1 day)
- Retinal vessel diameters(1 day)
- Retinal oxygen saturation(1 day)
- Retinal nerve fiber layer thickness(1 day)
研究者
Gerhard Garhofer
Section Head Ophthalmo-Pharmacology
Medical University of Vienna