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临床试验/NCT02766660
NCT02766660已完成不适用

Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy

Neon Hospital0 个研究点目标入组 102 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
主要终点
Macular thickness

研究概览

简要总结

The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls.

详细描述

One hundred and thirty two eyes of 66 patients with TAO and 72 eyes of 36 healthy controls were included in the study. Proptosis level was determined by Hertel exophthalmometer. Optic disc, peripapillary retinal nerve fiber layer and macula parameters were measured by OCT. All measurements were compared between the patients and age and sex-matched healthy controls.

研究设计

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

入排标准

年龄范围
12 Years 至 73 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient group consists the consecutive patients with thyroid associated ophthalmopathy consulted by endocrinology department.
  • The control group was chosen among healthy volunteers who have
  • no eye pathology,
  • 20/20 vision (corrected or uncorrected),
  • age and sex-matched with the patient group.

排除标准

  • For both groups, those who had
  • significant sight impairment,
  • high myopia ( < -5Diopters ),
  • high hyperopia ( > +3Diopters ),
  • optic disc anomaly,
  • vitreoretinal interface disease,
  • vascular and degenerative retinal diseases,
  • cornea or lens opacity, ocular surgery history,
  • glaucoma,
  • neurological diseases that can affect the visual field,
  • history of trauma, amblyopia,
  • diplopia,
  • keratitis,
  • history of topical or systemic steroid

结局指标

主要结局

Macular thickness

时间窗: one year (between Jan 2012 and Jan 2013)

Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.

Retinal nerve fiber layer thickness

时间窗: one year (between Jan 2012 and Jan 2013)

Retinal nerve fiber layer thickness (micrometer) was measured by optical coherence tomography in patient and control groups.

次要结局

  • Optic disc parameters(one year (between Jan 2012 and Jan 2013))

研究者

发起方
Neon Hospital
申办方类型
Other
责任方
Sponsor

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