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临床试验/NCT02383381
NCT02383381已完成不适用

Pre and Post-operative Rectus Muscle Insertion Site Changing Using Anterior Segment Optical Coherence Tomography in Strabismus Patients

Samsung Medical Center0 个研究点目标入组 30 人开始时间: 2014年2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
30
主要终点
The change of limbus-muscle insertion distance measured with AS-OCT

研究概览

简要总结

•Background and study aims : The investigators conducted this study to evaluate the movement of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT.

  • Who can participate? patients who underwent typical lateral rectus recession surgery for correcting intermittent exotropia
  • What does the study involve? Volunteers will attend a clinic for four visits over six months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is non-invasive test to evaluate operation site. The test only requires their cooperation when they undergo AS-OCT.
  • What are the possible benefits and risks of participating? This is non-invasive test for your postoperative follow up. Therefore, there will be no risks about this test.
  • Where is the study run from? Samsung Medical Center
  • When is the study starting and how long is it expected to run for? From Feb 2014 to Dec 2014

详细描述

The aim of this study is 1) to evaluate the reliability and accuracy of AS-OCT in the measurement of the lateral rectus (LR) insertion distance, 2)to investigate the longitudinal change of LR muscle insertion after strabismus surgery, and 3)to determine the effect of insertion movement on the angle of deviation after strabismus surgery. An AS-OCT scan of the LR muscle was performed every visits. Preoperative limbus-LR insertion distance was compared with intraoperative surgical caliper measurement of LR insertion using intraclass correlation coefficient analysis (ICC). Data on gender, age, degree of deviation (prism diopter), and spur-LR insertion distance using AS-OCT were collected at postoperative months 1,3 6.

研究设计

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

入排标准

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

入选标准

  • patients who underwent lateral rectus recession surgery for correcting intermittent exotropia

排除标准

  • previous ocular surgery
  • other ocular diseases except intermittent exotropia
  • amblyopia

结局指标

主要结局

The change of limbus-muscle insertion distance measured with AS-OCT

时间窗: baseline and 1.3.6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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