Assessment of Optic Nerve Radiation in Patients With Glaucoma and Ocular Hypertension by 7 Tesla Diffusion Tensor Imaging
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- High resolution functional and structural imaging of the visual pathway
研究概览
简要总结
Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular pressure (IOP) has been identified as the most important risk factor. However, some patients progress despite adequate IOP lowering while some subjects with elevated IOP never develop glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal range. Therefore, other factors must be involved. In the last years, studies using MRI have been performed and evidence has accumulated that also changes in retrobulbar structures are present, in particular in the lateral geniculate nucleus and the visual cortex. However, these studies were limited by the low spatial resolution of the MRI instruments used.
The investigators propose to overcome this problem by using an ultrahigh-field Magnetom 7T whole-body MR scanner (Siemens Medical, Germany) installed at the MR Centre of Excellence at the Medical University of Vienna. This scanner is equipped with a 32-channel head coil and the SC72 high-performance gradient system and is thus perfectly suited for structural and functional imaging. The aim of the present study is to investigate whether structural and functional parameters are altered in patients with primary open angle glaucoma (POAG), normal tension glaucoma (NTG), ocular hypertension (OHT) compared to healthy control subjects. The exact topographical survey of intracranial structures such as the LGN and the assessment of neuronal structures by DTI may allow for the better assessment of therapeutic responses to new neuroprotective agents.
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
- Single (Outcomes Assessor)
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
- •Healthy controls
- •Men and women aged over 18 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings
- •Patients with ocular hypertension
- •Men and women aged over 18 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings except presence of ocular hypertension (defined as untreated IOP ≥ 21 mmHg on at least three measurements in the medical history, no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test)
- •Patients with primary open angle glaucoma
- •Men and women aged over 18 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Diagnosis of manifest primary open angle glaucoma (defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and untreated IOP > 20 mmHg on at least three measurements in the medical history)
- •Mean Deviation in the visual field test ≥ 10dB
- •Patients with normal-tension glaucoma
- •Men and women aged over 18 years
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Diagnosis of normal-tension glaucoma (defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and untreated IOP ≤ 20 mmHg on at least three measurements in the medical history)
- •Mean Deviation in the visual field test ≥ 10dB
排除标准
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition as judged by the clinical investigator
- •Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Exfoliation glaucoma, pigmentary glaucoma, history of acute angle closure
- •Intraocular surgery within the last 6 months
- •Ocular inflammation or infection within the last 3 months
- •Pregnancy, planned pregnancy or lactating
- •Any metallic, electric, electronic or magnetic device or object not removable except dental fillings
- •Claustrophobia
研究组 & 干预措施
Primary Open Angle Glaucoma
30 patients with primary open angle glaucoma
干预措施: 7-Tesla MRI (Device)
Primary Open Angle Glaucoma
30 patients with primary open angle glaucoma
干预措施: Optical Coherence Tomography (Other)
Primary Open Angle Glaucoma
30 patients with primary open angle glaucoma
干预措施: Heidelberg Retina Tomography (Other)
Primary Open Angle Glaucoma
30 patients with primary open angle glaucoma
干预措施: Scanning Laser Polarimetry (Other)
Primary Open Angle Glaucoma
30 patients with primary open angle glaucoma
干预措施: Humphrey Perimetry (Other)
Primary Open Angle Glaucoma
30 patients with primary open angle glaucoma
干预措施: Applanation Tonometry (Other)
Normal Tension Glaucoma
30 patients with normal tension glaucoma
干预措施: 7-Tesla MRI (Device)
Normal Tension Glaucoma
30 patients with normal tension glaucoma
干预措施: Optical Coherence Tomography (Other)
Normal Tension Glaucoma
30 patients with normal tension glaucoma
干预措施: Heidelberg Retina Tomography (Other)
Normal Tension Glaucoma
30 patients with normal tension glaucoma
干预措施: Scanning Laser Polarimetry (Other)
Normal Tension Glaucoma
30 patients with normal tension glaucoma
干预措施: Humphrey Perimetry (Other)
Normal Tension Glaucoma
30 patients with normal tension glaucoma
干预措施: Applanation Tonometry (Other)
Ocular Hypertension
30 patients with ocular hypertension
干预措施: 7-Tesla MRI (Device)
Ocular Hypertension
30 patients with ocular hypertension
干预措施: Optical Coherence Tomography (Other)
Ocular Hypertension
30 patients with ocular hypertension
干预措施: Heidelberg Retina Tomography (Other)
Ocular Hypertension
30 patients with ocular hypertension
干预措施: Scanning Laser Polarimetry (Other)
Ocular Hypertension
30 patients with ocular hypertension
干预措施: Humphrey Perimetry (Other)
Ocular Hypertension
30 patients with ocular hypertension
干预措施: Applanation Tonometry (Other)
Healthy subjects
30 healthy control subjects
干预措施: Humphrey Perimetry (Other)
Healthy subjects
30 healthy control subjects
干预措施: 7-Tesla MRI (Device)
Healthy subjects
30 healthy control subjects
干预措施: Optical Coherence Tomography (Other)
Healthy subjects
30 healthy control subjects
干预措施: Heidelberg Retina Tomography (Other)
Healthy subjects
30 healthy control subjects
干预措施: Scanning Laser Polarimetry (Other)
Healthy subjects
30 healthy control subjects
干预措施: Applanation Tonometry (Other)
结局指标
主要结局
High resolution functional and structural imaging of the visual pathway
时间窗: once on the study day (approximately 1 hour)
The visual pathway will be imaged with 7-Tesla MRI. The images will be compared between the study groups.
次要结局
- Intraocular Pressure(once on the study day (1 minute))
- Visual field test(once on the study day (approximately 20 minutes))
- Retinal nerve fiber thickness(once on the study day (approximately 10 minutes))
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna