Study to Investigate Reproducibility of the New Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition (Software Version 6.0) in Comparison to Reproducibility of RNFL Scans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bruch's membrane opening-based minimum rim width (BMO-MRW)
研究概览
简要总结
The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new software (glaucoma premium module) with the well established peripapillary RNFL thickness measurements in patients with primary open angle glaucoma.
详细描述
The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with the new software (method B) and with the previous method of measurement (method A) in patients with glaucoma.
It is a prospective, not blinded, not randomised, monocentric study. Inclusion of 50 patients with a diagnosis of primary open angle glaucoma (POAG), that will be recruited from the ophthalmology outpatient department of the UniversityHospital Zurich, Switzerland. All patients will undergo a full ophthalmic examination including measurement of refraction, best corrected visual acuity, examination of anterior and posterior compartment and measurement of the intraocular pressure. On the same day they will have 3 OCT examinations with a new method of measurement (method B).On the same day the first 10 patients will undergo also 3 OCT examinations with the previous method (method A) and they will get an other 3 OCT examinations with method B by a second observer. For this 10 patients the next consultation (3 months +/- 1 month) the 3 OCT examinations with method B will be repeated by the first observer.
Primary objectives are coefficient of variations (COV) of method A and B; Intra-class-correlations (ICC) of method A and B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •diagnosis of POAG glaucoma
- •male and female patients aged 18 years or older, no upper limit
- •written informed consent
- •visual acuity of more or equal to 0.5 Snellen
- •refractive error between + /- 6.00 D spheric and under or equal than 2.00 D cylindrical
排除标准
- •history of surgery other than uncomplicated cataract surgery
- •disease affecting cornea, anterior compartment, lens, vitreous body
- •history of severe ocular disease, particularly diseases affecting the optic nerve, other than glaucoma
- •history of ocular trauma
研究组 & 干预措施
group 1
patient with a diagnosis of primary open angle glaucoma will undergo 'RNFL and BMO-MRW SD-OCT' measurements with Heidelberg Spectralis SD-OCT old protocoll and Glaucoma Premium Module (new) protocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).
干预措施: RNFL and BMO-MRW SD-OCT (Device)
结局指标
主要结局
Bruch's membrane opening-based minimum rim width (BMO-MRW)
时间窗: baseline and 3 months +/- 1 month
Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT
Retinal nerve fiber layer thickness (RNFL)
时间窗: baseline and 3 months +/- 1 month
Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT
次要结局
- Coefficient of variations (COV) of RNFL and BMO-MRW(baseline and 3 months +/- 1 month)
- Intra-class-correlations (ICC) of RNFL and BMO-MRW(baseline and 3 months +/- 1 month)