NCT00993174Unknown不适用
Amount of Surgery for Esotropia Under Topical Anesthesia
Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Amount of surgery required in mm and mm/degree of deviation angle
研究概览
简要总结
Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)
- •Visual acuity at least 20/40 in each eye
- •Cooperation for topical anesthesia
排除标准
- •Paretic or restrictive strabismus
- •Previous eye muscle surgery
- •Significant eye disease other than strabismus
结局指标
主要结局
Amount of surgery required in mm and mm/degree of deviation angle
时间窗: Immediate
次要结局
- Motor (deviation angle) and stereoacuity outcome(6 months)
研究者
研究点 (2)
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