Blood Flow of Ophthalmic Artery and Its Relationship to Structural Properties of the Optic Nerve and Intraocular Pressure in Glaucoma
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- The blood flow (ml/min) of the ophthalmic artery in patients with different types of glaucoma/ocular hypertension and healthy individuals will be measured with MRI
研究概览
简要总结
The main purpose of this project is to investigate the blood flow of the ophthalmic artery (OA) in patients with ocular hypertension, high tension glaucoma and normal tension glaucoma. It is also to study the influence of the intraocular pressure difference on OA blood flow in the two first groups. Furthermore, the investigators want to understand the relationship between ocular dynamics, blood flow and structural alternations of the optic nerve head (ONH). The rationale behind the study is to improve knowledge of the pathogenesis of glaucoma.
详细描述
The investigators will investigate the OA blood flow, intraocular pressure (IOP) and structural properties of the optic nerve. The investigators will include glaucoma patients as they believe that glaucoma may be caused by or influenced by OA blood flow. The investigators will include also patients with intraocular hypertension with and without pseudoexfoliation in order to study how changes in IOP interact with OA blood flow and the structural properties of the optic nerve in a group that does not develop glaucoma. In addition, the investigators will investigate patients that develop glaucoma in spite of a normal IOP. Therefore, the investigators will study three fundamentally different groups (G1, G2 and G3) of patients as well as a control group of healthy subjects (G4):
G1: Newly diagnosed and untreated Glaucoma (optic and visual field damage exists).
G2: Ocular hypertension with IOP ≥ 23 mmHg (i.e. only elevated eye pressure).
G3: Normal Tension Glaucoma.
G4: Healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed and untreated glaucoma patients
- •Treated normal tension glaucoma patients
- •Untreated patients with ocular hypertension
- •Subjects with healthy eyes
排除标准
- •Heart disease except treated hypertension
- •Intracranial pathology such as stroke, tumor, previous intracranial surgery
- •Insulin treated diabetes mellitus
研究组 & 干预措施
Blood flow pre&post IOP lowering
After measurement of blood flow with MRI and measurements of ocular parameters the patient receives the IOP lowering eye drop latanoprost once daily in one eye for approximately one week and then the measurements are are repeated in the same manner.
干预措施: Latanoprost (Drug)
结局指标
主要结局
The blood flow (ml/min) of the ophthalmic artery in patients with different types of glaucoma/ocular hypertension and healthy individuals will be measured with MRI
时间窗: Up to four years
次要结局
- The change of ophthalmic artery blood flow (ml/min) after a reduction in IOP in glaucoma and intraocular hypertension will be measured with MRI(Up to four years)
- The change of structural properties (μm) of the optic nerve after a reduction in IOP in glaucoma and intraocular hypertension will be measured with MRI(Up to four years)
- Difference in the ophthalmic artery blood flow (ml/min) measured with MRI in patients with ocular hypertension with and without pseudoexfoliation.(Up to four years)