Evaluation of the Change in the Deformation Amplitude Ratio, Integrated Radius and Stress Strain Index as Parameters of Corneal Biomechanics Post Different Laser Vision Correction Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC
研究概览
简要总结
In the study, The Investigators will compare the participates' corneal biomechanical properties including:
Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI)
All measurements will be taken before and after 3 months of LVC.
详细描述
Each Participant will undergo preoperative pentacam and corvis scan for his eyes and the 3 months post operative.
The participants are divided into 3 groups, one who underwent LASIK, one PRK and one Femto LASIK.
Collected data will before and after surgery will be compared in each arm and then the 3 arms will be compared together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age range 18 - 40 years.
- •Normal eyes with normal tomographic indices.
- •Patients with maximum mean refractive spherical equivalent (MRSE) of -7.00 diopters and with maximum astigmatism of -3.00 diopters.
排除标准
- •• Patients with any other coexisting corneal diseases.
- •Keratoconus eyes.
- •Eyes with previous refractive corneal surgery.
- •Patients with increased intraocular pressure.
结局指标
主要结局
Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC
时间窗: 3-6 months post operative
Comparison between in DA ratio (DA ratio) in patients undergoing LASIK, Femto LASIK and PRK. Comparison between changes in integrated Radius (IR) in patients undergoing LASIK, Femto LASIK and PRK. Comparison between changes in Stress strain index (SSI) in patients undergoing LASIK, Femto LASIK and PRK. Each indices will be compared before and after the Laser vision correction (LVC) procedure and the indices are not to be compared to each other to have have a fixed unit measure. I reviewed your comment and I dont see any conflicts, to clarify how multiple measurements will be aggregated to arrive at one reported value again I am going to measure each index and compare it with "itself' before and after 3 different LVC.
次要结局
未报告次要终点
研究者
Wessam Salem
Principle Investigator
Cairo University