Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- percentage of decrease of the initial angle of strabismus
研究概览
简要总结
Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only conventional recess-resect surgery. The patients were randomly located in one of the groups. The angles of horizontal deviation were compared between the groups before and six months after treatment.
详细描述
Patients underwent recess/resection surgery on the non-fixating eye using conventional technique under local anesthesia. The extent of surgery was determined based on our usual amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in 0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults with large angle horizontal strabismus
排除标准
- •oblique muscle disfunction
- •previous strabismus surgery
- •dissociated vertical deviation
- •paretic or restrictive deviation
研究组 & 干预措施
Saline solution plus surgery
Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure
干预措施: saline solution (Drug)
Botulinum toxin plus surgery
Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
percentage of decrease of the initial angle of strabismus
时间窗: 6 to 12 months
The percentages of decrease of the initial angle of strabismus were accessed by subtracting the final deviation of the initial deviation, dividing the result by the initial deviation and multiplying it by 100.
次要结局
- frequency of induced blepharoptosis(From the first to the last post operative day of follow up)
研究者
Nilza Minguini
MD, PhD
University of Campinas, Brazil