Spectral Domain Optic Cohaerence Tomography Imaging in Patients With Optic Nerve Head Drusen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in RNFL thickness
研究概览
简要总结
Optic nerve head Drusen are a mostly bilateral change of the optic nerve, eventually causing a slow, but progression loss of the visual fields. Characteristic are the crystalline deposits at the entrance of the optic nerve, the so called optic disc. The material consists of calcium, calcium phosphate, iron, but also amino acids and polysaccharides.
The diagnose is made or confirmed by different imaging modalities like ultrasound and auto-fluorescence imaging. By using the high-resolution imaging with spectral-domain optical coherence imaging (SD-OCT) the volume and deposits at the optic disc can be measured and quantified.
The purpose of this study whether and how defects in the visual fields are related to the deposits. Multimodal imaging of the optic nerve head is planned within the cross-sectional study, at two different time intervals (2 years). Changes in retinal fibre layer (RNFL) thickness and disc parameters are analyzed. Presence and extent of auto-fluorescent changes are evaluated. The prospective trial wants to clarify whether certain parameters at baseline indicate the further outcome and development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Drusen of the optic disc (as proven by ultrasound and clinical appearance)
排除标准
- •mental disability
- •loss of fixation
- •other eye diseases potentially leading to a loss of visual fields
结局指标
主要结局
Change in RNFL thickness
时间窗: baseline and 2 years
次要结局
- Change in auto-fluorescent areas(baseline and 2 years)
- Change in Drusen material(baseline and 2 years)
- Loss of Visual Fields(baseline and 2 years)