NCT01941485已完成不适用
A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery 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
- 60
- 主要终点
- The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.
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.
- •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
The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively
时间窗: Day 1 Postoperative
The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.
次要结局
- Manifest Refraction (Cylinder)(Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Wavefront Aberrometry(Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Incidence of Development of Opaque Bubble Layer (OBL)(Operation/Surgery (Day 1))
- Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap(Operation/Surgery (Day 1))
- The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively(Month 1 Postoperative)
- Manifest Refraction (Sphere)(Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Corneal Topography: Q-value(Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Uncorrected Visual Acuity (UCVA)(Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Best Corrected Visual Acuity (BCVA)(Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"(Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Percent Response by Category: "My Vision is a Concern in my Daily Life"(Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Percent Response by Category: "Driving at Night"(Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Flap Creation Time as Documented in the Log Files(Operation/Surgery (Day 1))
- Mean Contrast Sensitivity (CS)(Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)(Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Percent Response to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"(Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Percent Response by Category: "I Worry About my Vision"(Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Corneal Curvature as Measured by Keratometry(Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Corneal Topography: Anterior Chamber (AC) Volume(Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Corneal Topography: Anterior Chamber (AC) Depth(Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
- Corneal Topography: Angles(Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative)
研究者
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