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临床试验/NCT03516357
NCT03516357Unknown不适用

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic

Shanghai Eye Disease Prevention and Treatment Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年1月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
axial length measured by IOL-master

研究概览

简要总结

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

详细描述

1.The primary objective of the current study is to investigate changes in uncorrected visual acuity, diopter, accommodation, peripheral refraction, IOP, tear film quality, corneal thickness, corneal topography, corneal biomechanical parameters, objective optical quality, corneal and conjunctiva sensitivity and choroidal thickness for children with different diopters after wearing orthokeratology lenses; 2. Through measure long-term changes of these parameters, including corneal topography, axial length, peripheral refraction, objective optical quality and choroidal thickness, to explore occurrence and development regularity of myopia.

研究设计

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

入排标准

年龄范围
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • subjects were 6-16 years of age; 2.had no other ocular diseases aside from refractive error and no keratoconus (confirmed by pre-treatment corneal topography);
  • had an intraocular pressure (IOP) of <21 mmHg;
  • had an with-the- rule astigmatism (axes 180 ± 30) ≤ 1.50 D; 5.had a best corrected visual acuity(BCVA) ≤0.00 log MAR units in both eyes (Snellen equivalent to 20/20);

排除标准

  • had binocular vision problems; 2.use medications that might affect refractive development; 3.had history of ortho-k or contact lens wear;
  • Ocular surface diseases and other eye diseases which can cause abnormalities of ocular surface;
  • Patients with histories of ocular injury or surgery;
  • Corneal staining and decentration of lens after wearing Ortho-k.

结局指标

主要结局

axial length measured by IOL-master

时间窗: 2 years

measured by IOL-master

次要结局

  • corneal biomechanical parameters measured by Corvis-ST(2 years)
  • corneal morphological characteristics measured by Optikon 2000 corneal topographer(2 years)
  • IOP measured by Corvis-ST(2 years)
  • tear film quality measured by Keratography(2 years)
  • peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)(2 years)
  • corneal thickness measured by Corvis-ST(2 years)
  • accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)(2 years)
  • objective optical quality measured by OQAS visual quality analyzing system(2 years)
  • corneal and conjunctiva sensitivity measured by Cochet-Bonnet(2 years)
  • choroidal thickness measured by ocular coherence tomography(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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