NCT01941498已完成不适用
A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
研究概览
简要总结
The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to understand and sign an informed consent form.
- •Have refractive error (in both eyes) that requires refractive surgery.
- •Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
- •Myopia between 0.00 to -12.0 diopters pre-operatively.
- •Astigmatism between 0.00 to +6.00 diopters pre-operatively.
- •Willing and able to attend post-operative examinations per protocol schedule.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Participation in a clinical study within the last 30 days.
- •History of previous corneal surgery in either eye.
- •Multifocal ablations in either eye.
- •PRK or PTK surgery in either eye.
- •Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
- •Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
- •Unable to discontinue contact lens wear as specified in protocol.
- •History of Herpes simplex or Herpes zoster keratitis.
- •Active ocular rosacea.
- •Lyme disease.
- •History of dry eye that is unresponsive to treatment.
- •Severe ocular allergies.
- •Other medical conditions and use of medications as specified in protocol.
- •Pregnant or planning to become pregnant during the study.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
时间窗: Month 1
Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.
次要结局
- Wavefront Aberrometry(Baseline (Day 0), Month 6 Postoperative)
- Corneal Curvature as Measured by Keratometry(Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
- Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT(Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative)
- Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
- Mean Contrast Sensitivity (CS)(Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
- Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
- Mean Total Laser Treatment Time(Day 0 (surgery))
- Percent Response by Category: "I Worry About my Vision"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
- Mean Manifest Refraction (Sphere)(Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
- Mean Manifest Refraction (Cylinder)(Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
- Mean Laser Treatment Time(Day 0 (surgery))
- Percent Response by Category: "My Vision Is a Concern in My Daily Life"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
- Percent Response by Category: "Driving at Night"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
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