跳至主要内容
临床试验/NCT02235454
NCT02235454已完成不适用

A Prospective Evaluation of the Novel Glaucoma Premium Edition Software for Spectral Domain Optical Coherence Tomography

Duke University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
2
主要终点
Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)

研究概览

简要总结

The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for spectral domain optical coherence tomography (SDOCT) and if this software is superior to the conventional one that is currently used for SDOCT.

详细描述

The new GMPE software can now identify the ocular structures without input from the operator thus reducing operator induced errors. It also measures the thickness of the entire optic nerve head so as to allow for another anatomic area of the eye to be measured for assessment of glaucoma. In addition, it permits collection of retinal nerve fiber layer thickness data in three concentric circles instead of just one in order to account for different sizes of optic nerves.

Subjects who are receiving routine SDOCT (CPT 92133) will be recruited from the Duke Eye Center and its associated satellite clinics. Following informed consent, subjects undergo additional imaging using the SDOCT-GMPE software at the Duke Eye Center and its associated satellite clinics. The imaging results may be used in clinical care for the subjects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • capable and willing to provide consent
  • history of clinically-diagnosed glaucoma
  • at least 18 years of age

排除标准

  • unable or unwilling to give consent
  • under 18 years of age

研究组 & 干预措施

Glaucoma arm

Other

Consecutive patients with glaucoma will undergo non-invasive OCT imaging

干预措施: SDOCT-GMPE software (Device)

结局指标

主要结局

Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)

时间窗: imaging approximately 10 minutes

Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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