Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism
试验速览
- 阶段
- 不适用
- 入组人数
- 374
- 试验地点
- 8
- 主要终点
- Corrected Distance Visual Acuity (CDVA)
研究概览
简要总结
The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
详细描述
The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. ReLEx SMILE combines state-of-the-art femtosecond laser technology of the VisuMax with high-precision lenticule extraction to provide minimally invasive refractive correction. It is distinguished by its flapless, minimally invasive laser correction. A refractive lenticule is created in the intact cornea, but removed via a small incision. The changed form of the cornea corrects the refraction error. ReLEx SMILE for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. It is CE marked and available since 2011; more than 1 Million procedures have been performed worldwide. The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation and is therefore not yet CE marked.
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
- 是
入选标准
- •Normal corneal topography;
- •Predicted post-operative keratometry ≤51 D;
- •Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
- •Patients should be able to understand the patient information and willing to sign an informed consent;
- •Patients should be willing to comply with all follow-up visits and the respective examinations;
- •Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D);
- •The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively;
- •A difference between cycloplegic and manifest refractions of ≤1.00 D spherical equivalent in the eye to be treated;
排除标准
- •The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option.
- •Mixed astigmatism
- •Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.
结局指标
主要结局
Corrected Distance Visual Acuity (CDVA)
时间窗: 12 months
CDVA in logMar
次要结局
- side effects(12 months)
- patient satisfaction (Quality of Vision Questionnaire)(12 months)
- manifest refractive astigmatism(12 months)
- contrast sensitivity(12 months)
- spherical equivalent (SE)(12 months)