Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery Versus Conventional Phacoemulsification Using Divide-and-conquer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ultrasound cumulative dispersed energy (CDE)
研究概览
简要总结
Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Recently, it was demonstrated that with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced.
Objective: To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells.
Study design: Randomized, controlled trial. Study population: Patients with nuclear cataract of a grade ≥ 5. Intervention: Microinterventional endocapsular nuclear fragmentation. Main study parameters: Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.
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 (Outcomes Assessor)
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.
- •Informed consent.
- •Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III).
排除标准
- •Endothelial cell density (ECD) < 1500 mm-
- •Corneal opacification (any cause).
- •Corneal surgery or trauma.
- •Implant lens.
- •Refraction surgery.
- •Prior glaucoma surgery.
- •Pseudoexfoliation.
结局指标
主要结局
Ultrasound cumulative dispersed energy (CDE)
时间窗: During surgery
Phaco energy (Centurion, Alcon)
Change of corneal endothelial cell density (ECD)
时间窗: Preoperative and at 3 months
Central cell density will be assessed
次要结局
- Procedure time(During surgery)
- Postoperative complications(Up to 3 months)
- Peri-operative complications(During surgery)