Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser for Verification of Predicted Refractive Outcome Using EpiMaster Software Considering Epithelial Remodelling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Difference of SE(measured) and SE(predicted by EpiMaster)
研究概览
简要总结
The objective of the clinical investigation presented to is to verify predictions of post-operative PTK-PRK refractive outcome made by the EpiMaster application software by comparing these to post-operative clinical data after routine PTK-PRK treatments.
详细描述
The objective of the clinical investigation presented to is to verify predictions of post-operative PTK-PRK refractive outcome made by the EpiMaster application software by comparing these to post-operative clinical data after routine PTK-PRK treatments.
The EpiMaster application software is not used in this clinical investigation, consequently, it is a merely observational investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors
- •Patient present with myopic or myopic and astigmatic error
- •Patient will be able to understand the patient information and willing to sign an informed consent
- •Patient will be willing to comply with all follow-up visits and the respective examinations
排除标准
- •Exclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors
结局指标
主要结局
Difference of SE(measured) and SE(predicted by EpiMaster)
时间窗: 6 months
Percentage of eyes with SE6 months post-op "measured" - SEpredicted by EpiMaster within ±1.00D, with SE being the spherical equivalent
次要结局
未报告次要终点