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临床试验/NCT05748002
NCT05748002已完成不适用

Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2018年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
315
试验地点
1
主要终点
stable

研究概览

简要总结

To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Best corrected visual acuity (BCVA) ≥ 20/20;
  • No other eye diseases except myopia and astigmatism;
  • The cornea was transparent, and there was no cloud or pannus;
  • No clinical manifestation of keratoconus(Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring)

排除标准

  • corneal disease;
  • ocular trauma; 3) Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 4) Pregnant and lactating women;

结局指标

主要结局

stable

时间窗: one year

No alterations in morphological(Pentacam parameters, BAD\<0.42, TCT\<10μm) and biomechanical(Corvis ST, parametersCBI\<0.2, SPA1\<10) parameters between the first and last follow-up.

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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