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临床试验/NCT02622191
NCT02622191已完成不适用

Segmental Analysis of Retinal Layers and Measurement of Lamina Cribrosa Thickness in Patients With Asymmetric Primary Open-Angle Glaucoma

Wills Eye0 个研究点目标入组 33 人开始时间: 2012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
33
主要终点
Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements

研究概览

简要总结

The study aims to further understand glaucoma pathogenesis and progression by utilizing enhanced depth imaging optical coherence tomography to visualize and measure lamina cribrosa in vivo and segmentation technology to accurately delineate and measure boundaries of the retinal layers. Investigators will elaborate further on key concepts of lamina cribrosa thickness and trans-synaptic degeneration.

详细描述

Two important areas of the eye that need investigation in order to further understanding of glaucoma. First is the retina (part of the eye that converts images from the eye's optical system into electrical impulses sent along the optic nerve to the brain). Newer technology, Spectral Domain Optical Coherence Tomography (SD-OCT), allows us to look at different layers of the retina and carefully measure thickness of each layer. Second area is lamina cribrosa (a portion of the white part of the eye which has nerve fibers passing through it connecting the eye to the brain). If lamina cribrosa is thin, it is possible it may bend easily and disrupt nerve fibers. SD-OCT allows measurement of lamina cribrosa thickness.

Findings will help monitor changes that occur in the eye as a result of glaucoma.

Individuals with primary open-angle glaucoma and unilateral visual field defects were chosen as the main patient population (in addition to normal controls). By approximating each participants baseline anatomy using the fellow, "internal control" eye, investigators will be able to better determine if any changes occur in the macula or the lamina cribrosa as a result of glaucoma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Best-corrected visual acuity of 20/40 or better
  • No media opacities
  • Spherical equivalent refractive errors in a range of -6 to +6 diopters
  • Cylinder correction within 3.0 diopters.

排除标准

  • Age < 18 years old
  • Visual Acuity < 20/40
  • Nuclear sclerosis > +2
  • Corneal diseases
  • Contact lens use
  • History of posterior segment intraocular surgery
  • Systemic or ocular diseases that can cause visual field loss.

研究组 & 干预措施

Open-angle glaucoma

Experimental

Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient.

干预措施: Spectral domain Optical Coherence Tomography (Device)

Healthy Controls

Experimental

Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.

干预措施: Spectral domain Optical Coherence Tomography (Device)

结局指标

主要结局

Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements

时间窗: 1 examination, approximately one hour

Using Spectral Domain optical coherence tomography (SD-OCT), horizontal macular thickness of the lamina cribrosa (boundaries of the retinal layers) is measured in the eyes of each participant in microohms.

次要结局

未报告次要终点

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

L. Jay Katz MD

Principal Investigator

Wills Eye

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