Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Corneal wavefront analysis
研究概览
简要总结
To compare the efficacy to different profiles, direct head-to-head studies had been conducted. In one previous review study revealed that TG LASIK provided patient with better uncorrected visual acuity (UCVA) than WFO LASIK and WFG LASIK. In recent previous contralateral eye studies also showed that TG LASIK induced less postoperative higher-order aberration than WFO LASIK. However, these studies included only low-to-moderate myopia patients, for patients with high myopia (spherical equivalent > 6D), the effect of TG LASIK comparing with WFO LASIK had not been reported before.
The aim of our study is to analyze and compare the visual performance of TG LASIK and WFO LASIK in high myopia and low-to-moderate myopia patients, , particularly UCVA, corrected distance visual acuity (CDVA), contrast sensitivity (CS), and wavefront aberration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 50 years old
- •CDVA of both eyes could reach 0.1 logarithm of the minimum angle of resolution (logMAR)
- •stable refractive errors of myopia and astigmatism
排除标准
- •corneal opacities or irregularities
- •dry eye (Schirmer's test I ≤ 5mm)
- •amblyopia
- •coexisting ocular pathologies
- •non-dilating pupil
- •history of intraocular surgery, laser therapy, or retinopathy
- •optic nerve or macular diseases
- •estimated postoperative cornea residual stromal thickness less than 250 μm
- •pregnancy or under lactation
- •uncontrolled diabetic mellitus or systemic immune disease
- •refusal or unable to maintain follow-up
结局指标
主要结局
Corneal wavefront analysis
时间窗: 3-months postoperative visit
horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration
Contrast sensitivity
时间窗: 3-months postoperative visit
4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd).
Quality of vision questionnaire
时间窗: 3-months postoperative visit
A 11-item questionnaire, item scores range from 0 to 10 and higher item scores in questionnaire indicated more difficulty in achieving specific visual tasks
Visual acuity
时间窗: 3 months after surgery
uncorrected visual acuity and corrected distance visual acuity
次要结局
未报告次要终点
研究者
Chao-Kai Chang
Dean, Nobel Eye Institute
Taipei Nobel Eye Clinic