UV-Femtosecond Laser Assisted Lenticule Extraction Astigmatism NomogramStudy in Subjects With Myopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1. Astigmatism subjective (manifest dry) manifest refraction at postoperative follow-up visits
研究概览
简要总结
The purpose of this study is to obtain additional safety and effectiveness data on the WaveLight® Ultraviolet Femtosecond Laser System (UV fs-Laser) lenticule extraction procedure to assess the accuracy and assist in developing of the astigmatism nomogram across a defined dioptric range.
The treatment range is -0.5 to -10.0 diopters (D) spherical component and -0.25 to -2.0 D cylinder component of the manifest refraction. Subjects will undergo lenticule extraction treatment in the study eye and, if needed, a suitable approved refractive therapy in the fellow eye. Subjects will be expected to attend at least 7 scheduled study visits: A screening visit, a surgery visit, and 5 post-operative visits (Day 1, Week 1, Month 1, Month 3, Month 6) for an individual total duration of participation of approximately 7 months.
__PRESENT
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Myopia with sphere of -0.50 to -10.0 diopter and cylinder -0.25 to -2.0 diopter in study eye.
- •Stable refraction in the study eye.
- •Nondominant eye must qualify for treatment.
- •BCDVA better or Equal 0.14 logMAR in study and fellow eyes UCDVA Worse or equal 0.30 logMAR in study eye Presence of clear natural lens (non-cataractous eye) in study eye.
- •Minimum required endothelial cell density in study eye within defined age ranges.
排除标准
- •Study eye unable to focus for imaging and or treatment.
- •Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study.
- •Current use of medications with known ocular side effects and photosensitivity.
- •Ocular conditions in the either eye that may affect subject safety or impact study outcomes.
- •Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone.
结局指标
主要结局
1. Astigmatism subjective (manifest dry) manifest refraction at postoperative follow-up visits
时间窗: 1. Week 1, Month 1, Month 3, Month 06 | 2. Week 1, Month 1, Month 3, Month 06 | 3. From time of consent to study exit (cumulative to Month 6 postoperative)
[Time Frame: Week 1, Month 1, Month 3, Month 6]
时间窗: 1. Week 1, Month 1, Month 3, Month 06 | 2. Week 1, Month 1, Month 3, Month 06 | 3. From time of consent to study exit (cumulative to Month 6 postoperative)
2. Best Corrected Distance Visual Acuity (BCDVA) at postoperative follow-up visits
时间窗: 1. Week 1, Month 1, Month 3, Month 06 | 2. Week 1, Month 1, Month 3, Month 06 | 3. From time of consent to study exit (cumulative to Month 6 postoperative)
3. Ocular Serious Adverse Events
时间窗: 1. Week 1, Month 1, Month 3, Month 06 | 2. Week 1, Month 1, Month 3, Month 06 | 3. From time of consent to study exit (cumulative to Month 6 postoperative)
次要结局
- 1. Spherical subjective (manifest dry) refraction at postoperative follow-up visits(2. Uncorrected Distance Visual Acuity at all postoperative follow-up visits)