Clinical data collection of myopic patients after PTK-PRK with MEL excimer laser for verification of predicted refractive outcome using software EpiMaster considering epithelial remodelling
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
The objective of this observational clinical investigation is to collect pre- and post-operative clinical data of PTK-PRK treatment for refractive cases for verification of EpiMaster software. The EpiMaster software is designed to predict the refractive outcome post-operative considering the epithelium remodelling effecting the final manifest refraction. It is an open, non-randomized, observational, prospective, single centre clinical investigation. Patients who are potential candidates for primary refractive treatment with MEL 90 excimer laser device according to the user manual of a Carl Zeiss Meditec MEL 90 excimer laser.Each patient will be followed at 1, 3 , 6 and 12 months after PTK-PRK treatment. Data analysis will be done at 12 months. Any serious adverse events will be reported to ethics commiteee within 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •are according to the user manual of Carl Zeiss Meditec MEL (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
- •Thin corneas, keratoconus, corneal scars, severe eye allergies, eye infections, retinal and optic nerve diseases, pregnant females and immunocompromised patients.
研究者
Dr Sheetal Brar
ProSight Eye Hospital