Neurosurgery Resident
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- visual outcome.
研究概览
简要总结
Several studies have investigated factors associated with visual deterioration in BIIP patients. Severe papilledema, delayed diagnosis, high CSF opening pressure, obesity, and visual field defects have been associated with poor prognosis.
Optical Coherence Tomography has emerged as a valuable tool for monitoring retinal nerve fiber layer changes and detecting optic nerve damage. MRV abnormalities, particularly transverse sinus stenosis, have also gained increasing attention.
Recent literature emphasizes the importance of multidisciplinary management involving neurosurgeons, neurologists, ophthalmologists, and radiologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- ••Patients fulfilling modified Dandy criteria.
- •Age above 18 years.
- •Confirmed diagnosis of IIH:
- •Elevated opening pressure on lumbar puncture (>25 cm H2o) in lateral decubitus position).
- •Unremarkable neuroimaging (MRI/MRV) ruling out mass lesions, hydrocephalus, or venous sinus thrombosis.
- •Presence of papilledema documented by a neuro-ophthalmologist.
排除标准
- •Secondary causes of intracranial hypertension. (Evidence of an intracranial mass, hydrocephalus, or structural lesion on neuroimaging).
- •Cerebral venous sinus thrombosis.
- •Intracranial space occupying lesions.
- •Previous optic nerve diseases.
- •Severe systemic illness affecting vision.
- •Pregnancy (due to restricted medication options like Topiramate).
- •Previous intracranial surgery or CSF shunting procedures
研究组 & 干预措施
group 1 Idiopathic intracranial hypertension
干预措施: lumbo-peritoneal shunt (Procedure)
group 2 idiopathic increase intracranial hypertension
Conservative Management: Centered on lifestyle modifications for weight reduction, alongside targeted medical therapies including carbonic anhydrase inhibitors (e.g., acetazolamide) and/or topiramate.
干预措施: Conservative Management: Centered on lifestyle modifications for weight reduction, alongside targeted medical therapies including carbonic anhydrase inhibitors (e.g., acetazolamide) and/or topiramate. (Drug)
结局指标
主要结局
visual outcome.
时间窗: 6 months
* Visual Acuity (VA): Best-corrected visual acuity using the Snellen chart (converted to LogMAR for statistical analysis). * Funduscopy: Grading of papilledema using the Frisén Scale (Grades 0-5). * Visual Field Testing: Automated perimetry (Humphrey Visual Field, 24-2 or 30-2 program) to detect blind spot enlargement or peripheral field loss Optical Coherence Tomography (OCT): Measuring Retinal Nerve Fiber Layer (RNFL) thickness and total macular volume to objectively quantify axonal swelling.
次要结局
- Requirement for surgical intervention.(6months)
研究者
Ahmed Talaat Roshdy
Idiopathic intracranial hypertension: prognostic factors and multidisciplinary management
Sohag University