Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 2
- 主要终点
- Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
研究概览
简要总结
Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)
Two sub-categories of phacoemulsification coexist :
Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Male or female aged ≥ 18 years
- •Patients undergoing cataract surgery
- •Visual acuity Monoyer scale <6/10e (< +0.2 logMar)
- •Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
排除标准
- •insulin-dependent diabetes and /or diabetic retinopathy
- •corneal disease: keratitis, dystrophy, corneal degeneration
- •Any disease of intraocular pressure
- •Any disease of the anterior segment
- •Low preoperative endothelial cell density < 1500 c/mm²
- •Combined surgery (cataract + corneal transplant, cataract + glaucoma surgery, cataract +vitrectomy ...)
- •Risk factors for surgical per-operative complication
- •Pregnancy, lactation
- •Ward of court
- •Patient not covered by the Social Security scheme
研究组 & 干预措施
Divide and Conquer
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
干预措施: Divide and Conquer (Procedure)
Subluxation
Nucleus is hydrodissected until it lilts above the capsular bag, rotated to face the incision then tumbled and emulsification continues from the opposite equator outside in until complete
干预措施: Subluxation (Procedure)
结局指标
主要结局
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
时间窗: 12 month
次要结局
未报告次要终点