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临床试验/NCT00767884
NCT00767884终止不适用

Effect of Panretinal Photocoagulation on Optic Nerve Head Topography and Nerve Fiber Layer Parameters

University of Nebraska2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2008年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
2
主要终点
Changes in optic nerve head topography before and after panretinal photocoagulation

研究概览

简要总结

The purpose of this study is to evaluate the optic nerve head changes consequent to panretinal photocoagulation done for diabetic retinopathy.

详细描述

Panretinal photocoagulation thermally ablates the retina to effect the regression of the neovascular process seen with diabetic retinopathy.2-6 Photocoagulative damage also damages the nerve fiber layer in the process. Since this should theoretically be associated with loss of nerve fibers it is expected to manifest as changes in optic nerve head cupping. There is no available literature to support this hypothesis. In fact the only available study done of the subject refuted the hypothesis.7 The study had a retrospective design and was done before any of the current technology to evaluate optic nerve head morphology was available.

Patients with concurrent glaucoma and diabetes often undergo panretinal photocoagulation as a part of their diabetes treatment. Optic disc cupping is a standard outcome measure for glaucoma diagnosis and progression. If PRP were to cause increased cupping, this can be a significant confounder in determining glaucoma progression based on optic nerve cupping. The findings of the study will help us determine as to how much cupping can be attributed to the PRP, if any at all.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Any patient with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy otherwise undergoing panretinal photocoagulation for treatment.

排除标准

  • Any patient with uncontrolled glaucoma (IOP above target on any occasion in the preceding 6 months) or other optic neuropathy that may confound the analysis of optic nerve head morphology.
  • Patients with media opacities (significant cataract, corneal opacity, vitreous hemorrhage) precluding imaging of the optic nerve.
  • No PRP done in the previous 6 months.

结局指标

主要结局

Changes in optic nerve head topography before and after panretinal photocoagulation

时间窗: 3 years

Compare changes in optic nerve head topography before and after panretinal photocoagulation (PRP)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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