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临床试验/NCT03010748
NCT03010748Unknown不适用

Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50,000
试验地点
1
主要终点
corneal thickness

研究概览

简要总结

Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used before and after clinical refractive surgery, we will collect the corneal morphological and biologic parameters of the population under refractive surgery screening in refractive surgery centers around the country, and construct corneal morphology database in different living areas of Chinese people. Based on this, compared with the suspected keratoconus and keratoconus population, the screening criteria and reference standards accord with the characteristics of keratoconus of Chinese ethnic will be achieved.

详细描述

The safety of refractive surgery has always been the focus of attention, keratoconus screening is the most important part for the preoperative examination of refractive surgery. Favorable tools and appropriate indicators are the premise of fast and accurate screening, and the corneal morphology from various regions of China have various characteristics, the use of uniform standards developed by foreign screening will always induce a lot of problems, for example, the differences of cornea morphological features between European and American ethnic and Chinese race, as well as the corneal morphometric indicators between various regions of China, will cause varying degrees of false-positive or false-negative screening results. Based on this, in order to further improve the safety of refractive surgery effectively and to obtain the effective and accurate screening of suspected keratoconus population, this study will be conducted to collect the corneal morphological characteristics database of Chinese people from all over the country, and to develop a database of Chinese ethnographic characteristics for screening keratoconus indicators and reference valuable to guide clinical screening and surgical design.

研究设计

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

入排标准

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

入选标准

  • No less than 18 years old, in good health, have no active disease in the body and eye, have permanent resident status and have lived in the local area for at least 5 years (please mark the nation).

排除标准

  • Eye diseases, glaucoma, ocular hypertension, glaucoma patients with normal pressure, fundus lesions, ptosis and other eyelid abnormalities.

结局指标

主要结局

corneal thickness

时间窗: preoperative

次要结局

  • anterior chamber angle measured by the Pentacam system(preoperative)
  • anterior chamber depth measured by the Pentacam system(preoperative)
  • kapple angle measured by the Pentacam system(preoperative)
  • corneal diameter measured by the Pentacam system(preoperative)
  • coma aberration measured by the Pentacam system(preoperative)
  • aspherical index measured by the Pentacam system(preoperative)
  • spherical aberration measured by the Pentacam system(preoperative)
  • corrected distance visual acuity(preoperative)
  • uncorrected distance visual acuity(preoperative)
  • corneal volume measured by the Pentacam system(preoperative)
  • introcular pressure(preoperative)
  • corneal curvature measured by the Pentacam system(preoperative)
  • refractive diopter(preoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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