An Open-label Investigator-masked Study Comparing Femtosecond Laser Assisted With Conventional Phacoemulsification Cataract Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Effective Phaco Time
研究概览
简要总结
Cataract surgery is among the world's most frequently performed operations. It involves removal of an opaque lens from the human eye and implantation of an artificial lens. The operation is performed under local anaesthesia using ultrasound technology, by which the lens is emulsified and removed by suction.
Femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can improve the quality of cataract surgery and provide a new best possible standard of quality. In contrast to the conventional method the capsulotomy and the fragemntation are fully automatically performed with a femtosecond laser. In addition, the lens is fragmented by the laser, which substantially facilitates its removal and reduces the operation time.
Study to investigate whether the femtosecond laser cataract surgery causes any significant differences in clinical outcomes as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC).
Effective phako time (EPT) is defined as duration of phakoemulsifikation of the crystalline lens.
EPT of conventional surgery at intraoperative visit > EPT oflaser-assisted surgery at intraoperative visit
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
- Single (Investigator)
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
- •Age 18 years
- •related cataract
- •Ability to follow instructions from the treatment team
- •Both eyes to receive surgery
排除标准
- •Narrow pupils (in ther. mydriasis <6mm)
- •Narrow orbits
- •Sunken eyes
- •manifest glaucoma treated with anti-glaucomatous therapy or prior surgery
- •Conditions that pose a high risk of complications during surgery
- •Known sensitivity to planned concomitant medications
- •Patients with disorders of the ocular muscle, such as nystagmus or strabismus
- •Patients who are blind on one eye
- •Acute or chronic systemic and/or ocular illnesses that are clinically significant and will increase the risk to the subject or confound the outcomes of this study, such as but not restricted to diabetes mellitus, autoimmune/rheumatic or connective tissue diseases, dementia or epilepsy.
- •Patients who are pregnant or nursing
- •Patients who do not give informed consent
研究组 & 干预措施
Victus Group
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
干预措施: Victus (Device)
Conventional Group
The Conventional Group acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually
干预措施: Conventional Phaco (Device)
结局指标
主要结局
Effective Phaco Time
时间窗: surgery day
EPT of the conventional cataract surgery (mesured intraoperativ = Visit 2) is smaller or equal to the EPT of the Laser-assisted cataract surgery (meausred intraoperativ = Visit 2)
次要结局
- IOL overlap(1 month, 3 and 6 months)
- IOL Centration(1 month, 3 and 6 months)
研究者
Matthias Bolz
MD
Augenabteilung Allgemeines Krankenhaus Linz