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临床试验/NCT01901406
NCT01901406已完成不适用

Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年7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
24
试验地点
1
主要终点
Titmus test (arc of second)

研究概览

简要总结

Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.

研究设计

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

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy
  • Age more than 20 years and less than 90 years old

排除标准

  • secondary epiretinal membrane due to retinal surgery,
  • impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract
  • glaucoma patients
  • complication during vitrectomy (ex. Retinal tear, silicone oil injection, ...)
  • other retinal disease except epiretinal membrane
  • other ocular surgery history within 3 months
  • intellectual problems or illiterate whom could not obtained informed consent

结局指标

主要结局

Titmus test (arc of second)

时间窗: from Initial screening day before surgey to postoperative 6 months

Changes of Stereopsis tested by TNO test (arc of second)

时间窗: from Initial screening day before surgey to postoperative 6 months

Stereopsis is normal binocular vision. Its presence or absence is an important indicator of the state of binocularity. The TNO test is graded to provide retinal disparities ranging from 15 to 480 second of arc.

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 (1)

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