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临床试验/NCT03786146
NCT03786146Unknown不适用

Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation

Assiut University0 个研究点目标入组 30 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.

研究概览

简要总结

Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic retinopathy. It is recognized that laser expansion into the retina may be associated with photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss.

Panretinal photocoagulation can cause alteration in retinal vascular permeability therefore, retinal thickness may be increased including retinal nerve fiber layer. On the contrary, it can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber layer thickness in the latter follow up period.

Peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.

详细描述

Pre laser assessment:

  • Assessment of medical and family history
  • Refraction and best corrected visual acuity
  • Anterior segment examination using binocular slit lamp bi-microscopy.
  • Posterior segment examination.
  • OCT scan of peripapillary area

Post laser assessment ( at 1,3 and 6 months):

  • Refraction and best corrected visual acuity.
  • Anterior segment examination using binocular slit lamp bi-microscopy.
  • Posterior segment examination.
  • OCT scan of peripapillary area.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a clinical diagnosis of proliferative diabetic retinopathy.
  • Treated by panretinal photocoagulation.
  • Age between 40-70 years old.

排除标准

  • Patients with densely opaque media (as dense cataract or vitreous hemorrhage).
  • Glaucomatous patients.
  • Any other associated retinopathy.

结局指标

主要结局

Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.

时间窗: 6 months post laser treatment.

A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

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

Rania M. Goda

principle investigator

Assiut University

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