NCT00753831已完成4 期
Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Aurolab
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Ptosis Correction
研究概览
简要总结
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis
详细描述
Silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.The elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. In the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital Ptosis
- •Severe Ptosis (MRD<0)
- •Poor levator function (<4mm by Berke's method)
- •Myogenic Ptosis (Myasthenia gravis)
- •Chronic progressive external ophthalmoplegia
- •Neurogenic Ptosis (Third cranial palsy)
- •Blepharospasm
- •Ptosis caused by trauma
排除标准
- •Acquired Ptosis
- •Horners syndrome
- •Blepharochalasis/Dermatochalasis
- •Mechanical Ptosis
- •Mild or Moderate Ptosis (MRD 1>1)
- •Good or fair levator function (>4 mm by Berke's method)
- •Previous Ptosis surgery
- •Ptosis associated syndromes/Other anomalies including
- •Marcus Gunn jaw winking syndrome
- •Blepharophimosis syndrome
- •Dry eye syndromes
- •Corneal anesthesia
- •Medical/Pediatric/Anesthesia condition contraindicating to surgery or anesthesia
- •Nystagmus where adequate measurements could not be done
- •Uncorrected vertical squint of any sort
结局指标
主要结局
Ptosis Correction
时间窗: 15th day, 90th day postoperatively
次要结局
- Adverse Events(15th day, 90th day postoperatively)
研究者
研究点 (2)
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