Post-Market Clinical Follow-up Study on SMILE Treatment of Myopia With and Without Astigmatism by VISUMAX 800
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 5
- 主要终点
- Early visual acuity
研究概览
简要总结
The primary objective of this PMCF investigation is to systematically collect safety and effectiveness data with the VISUMAX 800 laser in clinical daily routine SMILE use for the purpose of post market surveillance.
详细描述
The present PMCF study is a prospective, non-randomized, international multi-center study without control group including patients with myopia or myopia combined with astigmatism undergoing SMILE with the VISUMAX 800 femtosecond laser in daily routine use.
In this PMCF study, at maximum 474 eyes of consecutive subjects will be consented, enrolled, treated and followed up to 6 months postoperatively at 4 to 5 sites. The treatments, which will be done bilateral, shall be equally distributed between the sites as far as possible.
The subjects will be 18 years of age or older, who suffer from myopia of up to -10 D with or without astigmatism of up to 5 D, and are suitable for SMILE treatments, fulfil all inclusion criteria and not fulfil any of the exclusion criteria.
The expected duration of the is 16 months (site initiation to closeout visit).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Myopia up to -10 D with and without astigmatism up to 5 D
- •Age of 18 years or older
- •Pre-operative CDVA of 20/25 or better in each eye
- •Patient shall be willing to comply with all follow-up visits and the respective examinations
- •Patients should be able to understand the patient information and willing to sign an informed consent.
- •Contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baseline measurements in case of soft contact lenses
排除标准
- •No monovision treatments (target sphere may not be more negative than -0.25 D)
- •The patient may not participate in other ophthalmologic studies except in VEMOS study at site Aarhus.
- •Any impaired person (minors, pregnant or breast-feeding women or persons incapable of giving consent) are definitely excluded from the study.
- •The patients presenting at least one of the contraindications stated in User Manual of the VISUMAX 800 option ReLEx SMILE must not be included in this clinical investigation
结局指标
主要结局
Early visual acuity
时间窗: 1 week
Determination of the difference between post-operative UDVA and pre-operative CDVA with a half width of 95% confidence-interval of 0.02 logMAR
Accuracy of astigmatism
时间窗: 6 months
Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4%
Accuracy of manifest spherical equivalent
时间窗: 6 months
Determination of the percentage of eyes with MRSE-target SE within ±0.5D with a half width of 95% confidence-interval of 4%
Side effects and complications
时间窗: 6 months
Determination of the rates of side effects and intra-operative complications with an accuracy, which in case of a zero frequency allows the conclusion of being lower or equal than 1%, which means that the upper confidence limit is 1%.
次要结局
- CDVA(6 months)
- Cylinder vector analyses(6 months)
- UDVA(6 months)
- Mesopic contrast sensitivity(6 months)
- Predictability and accuracy(6 months)
- Stability(between 3 months and 6 months)
- Corneal wave-front, change against baseline(6 months)
- Centration(during the procedure)
- Patient Questionnaire(6 months)