NCT01088568Unknown不适用
Randomized, Prospective Comparison of the Outcome of TICL and Q Value Customized LASIK for the Correction of Myopia With Astigmatism
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
研究概览
简要总结
The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.
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
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 21-45 years old
- •Documented stable refraction for at least 1 year
- •(-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D
- •BSCVA: 20/20 or better
- •Pupil diameter: smaller than 7mm under mesopic condition
- •Contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively
排除标准
- •Evidence of progressive or acute disease
- •Evidence of connective tissue disease or clinically significant atopic disease
- •ACD less than 2.8mm from endothelium
- •ECC less than 2200 cells/mm2
- •Narrow angle of anterior chamber
- •Residual stromal thickness less than 280 microns
研究组 & 干预措施
TICL group
Experimental
干预措施: the implantation of toric implantable collamer lens (Procedure)
LASIK group
Active Comparator
干预措施: customized laser-assisted in situ keratomileusis (Procedure)
结局指标
主要结局
Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK
时间窗: 1week, 1,3,6 months
次要结局
- Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK(1, 3, 6 months)
研究者
研究点 (1)
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