Effect of Trabeculectomy on Peripapillary Retinal Nerve Fiber Layer Thickness Using Spectral Domain Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- change of retinal nerve fiber layer thickness
研究概览
简要总结
At present, trabeculectomy is the most common performed and effective surgical method of filtration surgery for patients with medically uncontrolled glaucoma.
The aim of this prospective observational case study is to determine changes of the peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence tomography in patients with glaucoma after surgical reduction of intraocular pressure.
详细描述
Baseline and postoperative measurement of the peripapillary retinal nerve fiber layer (RNFL) thickness will be performed using the following spectral domain optical coherence tomography (OCT): Cirrus™ HD-OCT (Carl Zeiss Meditec) and Spectralis® Heidelberg-Engineering.
The main outcome measures will be changes in overall and quadrant RNFL thickness with respect to reduction in intraocular pressure (IOP), correlation between RNFL thickness and alteration in visual field and predictive factors of postoperative IOP-reduction and changes of RNFL thickness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or secondary open angle glaucoma
- •target intraocular pressure under medical treatment was not reached
- •progression of visual loss
- •best corrected visual acuity of 20/100 or more
- •spherical equivalent refraction of -8.0 to +4.0 D
- •perimetry: less than 20% false positive answers
排除标准
- •primary or secondary angle closure glaucoma
- •congenital glaucoma
- •normal tension glaucoma
- •neovascular glaucoma
结局指标
主要结局
change of retinal nerve fiber layer thickness
时间窗: 6 months
study was terminated
次要结局
未报告次要终点
研究者
Juliane Matlach, MD
Dr.
University Eye Hospital, Würzburg