A Single Centre Randomized Eye Study to Compare the Performance and Safety of Femtosecond Laser-assisted Cataract Procedures With Conventional Ultrasound-assisted Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Effective Phaco Time (EPT)
研究概览
简要总结
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract surgery.
详细描述
Cataract Surgery according to conventional procedure, with the exception of two steps (Capsulotomy and Lens Fragmentation) which are performed with a Femtosecond Laser in the study group. Used equipment for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment (group A) Cataract surgery will be performed conventionally, this means the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification. (group B)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens Implantation
- •Able to co-operate with the docking system for the femtosecond laser
- •Clear corneal media
- •50 years of age or older
- •Willing and able to return for scheduled follow-up examinations
排除标准
- •Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
- •Maximum K-value that exceeds 58D
- •Minimal K-value of less than 37D
- •Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
- •Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
- •Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
- •Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
- •Known sensitivity to planned concomitant medications
- •History of lens or zonular instability
- •Keratoconus or keratectasia
- •Immune compromised or diagnosis of connective tissue disease, clinically sign. atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study PI.
- •Anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured from the corneal endothelium.
- •Extensive corneal scarring
- •Developmental disability or cognitive impairment (would preclude adequate comprehension of the Informed Consent (IC) form and/or the ability to record the study measurements)
- •Concurrent participation in another ophthalmological clinical study
研究组 & 干预措施
Femto LDV Z8
Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
干预措施: Femto LDV Z8 (Device)
Manual capsulorhexis&lens fragmentation
The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification
干预措施: Manual capsulorhexis&lens fragmentation (Device)
结局指标
主要结局
Effective Phaco Time (EPT)
时间窗: day of surgery
Effective Phacoemulsification Time (EPT): EPT for eyes receiving Intervention A being statistically same or lower than EPT for eyes receiving Intervention B at p\<0.05 will be considered positive for superior efficacy of application of FEMTO LDV Z8 over the manual procedure Effective Phaco Time is a unit. It is commonly understood in the area of cataract surgery to be the standard way to describe phaco energy during a procedure over different manufactured phaco devices. Effective phaco time is the total phaco time at 100 percent phaco power. It can be less than the total foot-pedal time. Less EPT indicates proportionately less energy delivered to the eye thereby reducing the side effects of phaco power.
次要结局
- Ease of Phacoemulsification(during surgery)
- Number of Participants With Complete Treatment Pattern(during surgery)