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临床试验/NCT01612416
NCT01612416已完成不适用

Comparison of Ganglion Cell and Retinal Nerve Fiber Layer Thickness in Primary Open Angle Glaucoma and Normal Tension Glaucoma With Spectral Domain OCT

Inonu University2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
2
主要终点
Ganglion cell complex, retinal nerve fiber layer and retinal thickness measurements of glaucoma patients using spectral domain OCT.

研究概览

简要总结

The aim of this study is to examine whether there is a difference in macular ganglion cell complex thickness and retinal nerve fiber layer thickness in early-stage Primary open angle glaucoma and normal tension glaucoma with spectral domain OCT.

详细描述

Glaucoma is a progressive optic neuropathy characterized by gradual degeneration of neuronal tissue in which retinal ganglion cells (RGCs) are injured, leading to the loss of the visual field.Recent studies have separately demonstrated a reduction in the macular retinal thickness and in the retinal nerve fibers in both POAG and NTG.It has been demonstrated that in early stage NTG macular GCC thickness showed a strong correlation with thickness of the RNFL. However there have yet to be any reports regarding the comparison of macular thickness, ganglion cell complex and retinal nerve fiber layer between POAG and NTG with RS-3000 RetinaScan at early stage.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
28 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The POAG group inclusion criteria were;
  • IOP higher than 21 mmHg before treatment on three different visits,
  • Best corrected VA of 20/25 or better with a spherical equivalent within ±5 D and a cylinder correction within +3 D;
  • An open angle confirmed by gonioscopy.
  • Glaucomatous optic disc damage defined as by the presence of glaucomatous optic neuropathy like rim thinning (diffuse or local), cupping, notching, and a cup/disc ratio >0.2 with asymmetry.
  • NTG group were included if;
  • They had the same optic disc and visual field criteria as for the POAG patients with the exception that their IOP was as ≤21 mmHg on three separate visits without any glaucomatous treatment.
  • The control group
  • Who had no ocular disease
  • Who had not undergone ocular surgery or laser procedures.
  • With a normal anterior segment, open angles, and normal posterior segment findings also normal optic nerve head appearance in their ophthalmic examination.
  • The IOP measurements were lower than 21 mmHg, and full-threshold 30-2 HFA were also within normal limits in the control group.

排除标准

  • Subjects with any retinal disease, diabetes mellitus, or neurological disease or who had undergone ocular surgery and laser procedures.
  • Subjects with pseudoexfoliation glaucoma and pigmentary glaucoma were excluded.

结局指标

主要结局

Ganglion cell complex, retinal nerve fiber layer and retinal thickness measurements of glaucoma patients using spectral domain OCT.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Penpe Gul Firat

Principal Investigator

Inonu University

研究点 (2)

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