NCT05748002已完成不适用
Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index
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
- 是
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
研究点 (1)
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