Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Corneal Astigmatism one year after the intervention
研究概览
简要总结
The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure including arcuate incisions (AI) correcting astigmatism, also referred to as arcuate keratotomy (AK). The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery and additionally perform arcuate keratotomy in individuals with more than 1.0 Diopter (dpt) of astigmatism. Cataract surgery will be performed in subjects who have signed an informed consent form.
Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: postoperative refraction, visual acuity, slitlamp examination, and corneal topography
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract necessitating lens extraction and posterior IOL implantation
- •Regular corneal astigmatism between 1.0 and 2.5 DPT
- •Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
排除标准
- •Corneal abnormality
- •Preceding ocular surgery or trauma
- •Uncontrolled glaucoma
- •Proliferative diabetic retinopathy
- •Iris neovascularization
- •History of uveitis/iritis
- •Microphthalmus
- •Recurrent intraocular inflammation of unknown etiology
- •Blind fellow eye
- •Uncontrolled systemic or ocular disease
结局指标
主要结局
Corneal Astigmatism one year after the intervention
时间窗: 1 year follow-up
H0: no change in postoperative refraction astigmatism H1: change in postoperative refraction astigmatism
次要结局
- Precision and reproducibility of corneal cut depth(1 year follow-up)
研究者
Rupert Menapace
Clinical Professor
Medical University of Vienna