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临床试验/NCT03257020
NCT03257020已完成不适用

The Comparison of Bruch's Membrane Opening-minimum Rim Width and Retinal Nerve Fiber Layer Thickness and Their Combinational Index Using Artificial Neural Network

Pusan National University Hospital1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
402
试验地点
1
主要终点
Bruch's membrane opening - minimum rim width (BMO-MRW)

研究概览

简要总结

This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT. SD-OCT exam will be performed to all patients in this study.

详细描述

spectral domain optical coherence tomography, SD-OCT, (Heidelberg Engineering, Heidelberg, Germany) is a widely used commercial device in ophthalmology field. For a long time, retinal nerve fiber layer (RNFL) thickness was measured with OCT to detect and follow up glaucoma patients. Bruch's membrane opening - minimum rim width (BMO-MRW) is relatively new parameter which measures the minimum distance between Bruch's membrane opening to internal limiting membrane (ILM). BMO-MRW,a new parameter, is known to have better diagnostic performance than RNFL thickness and recently, many researches has been performed on this new parameter. SD-OCT can measure RNFL thickness and BMO-MRW at the same time. The test procedure is not different from RNFL thickness measurement but only software implemented in OCT device calculates BMO-MRW as well as RNFL thickness. The investigators are going to compare these two parameters and find out the relationship between two parameters.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years with a clear cornea and clear ocular media
  • BCVA ≥ 20/40
  • Refractive error within ± 6.0 diopters (D) of 0 and astigmatism ± 3.0 D of 0

排除标准

  • secondary glaucoma
  • corneal abnormalities
  • non-glaucomatous optic neuropathies
  • previous trauma
  • ocular surgery or laser treatment
  • any other eye disease except glaucoma.

结局指标

主要结局

Bruch's membrane opening - minimum rim width (BMO-MRW)

时间窗: 5~10 minutes

SD-OCT will be performed to the patients to measure BMO-MRW by trained glaucoma specialist.

次要结局

  • Retinal nerve fiber layer (RNFL) thickness(5~10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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