Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery - FLAME
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Central Macular Thickness
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. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.
Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.
Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.
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
- •Bilateral Age-related cataract necessitating lens extraction and posterior IOL implantation
- •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
- •Macular degeneration
- •Iris neovascularization
- •History of uveitis/iritis
- •Microphthalmus
- •Recurrent intraocular inflammation of unknown etiology
- •Blind fellow eye
- •Uncontrolled systemic or ocular disease
研究组 & 干预措施
Femtosecond Laser assisted Cataract Surgery
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.
干预措施: Femtosecond Laser (Device)
Manual Cataract Surgery
Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.
干预措施: Manual Cataract Surgery (Other)
结局指标
主要结局
Central Macular Thickness
时间窗: Baseline to 6 weeks postoperative
Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)
次要结局
- Influence of lens density on quantitative autofluorescence(Baseline to 1 weel, 3 weeks and 6 weeks postoperative)
- Central Macular Thickness(Baseline to 1 week, 3 weeks, 6 weeks postoperative)
研究者
Rupert Menapace
Principal Investigator
Medical University of Vienna