Botulinum Toxin Type A for Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measurement of the palpebral fissure
研究概览
简要总结
The purpose of this study is to associate the use of botulinum toxin type A for patients with keratoconus to demonstrate that tension eyelid has an important role in disease progression.
详细描述
Subcutaneous injection of botulinum toxin type A will be performed at two points in a nasal and temporal extent of the orbicularis muscle of a group of patients with keratoconus (Botulinum toxin A group).The idea is to evaluate the change in palpebral fissure in patients from group botulinum toxin A over a period of 18 months.The measurements of the palpebral fissure will be performed by the Image J (version 1.34s) program, developed by the National Institutes of Health (USA).The unit of measure is the millimetre.The patients of the botulinum toxin A group will be compared with a control group, without any intervention.
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
- None
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with documented keratoconus
- •best-corrected visual acuity measurable at refraction test
- •age between 10-40 years
- •good health
- •understand the procedure and its limitations
排除标准
- •only one functional eye
- •previous ocular surgery
- •concurrent corneal infection and other ocular diseases that modified the visual acuity
- •known allergy to botulinum toxin
- •pregnancy
- •poor collaboration for performing the examinations and the procedure
研究组 & 干预措施
Botulinum toxin type A
The group that will be subjected to the injection of botulinum toxin (subcutaneous injection of botulinum toxin type A).Subcutaneous botulinum toxin A injection will be performed in this group, (2.5 units per point application), at two points in a nasal and temporal extent of the orbicularis muscle.
干预措施: Subcutaneous injection of botulinum toxin type A (Procedure)
Botulinum toxin type A
The group that will be subjected to the injection of botulinum toxin (subcutaneous injection of botulinum toxin type A).Subcutaneous botulinum toxin A injection will be performed in this group, (2.5 units per point application), at two points in a nasal and temporal extent of the orbicularis muscle.
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Measurement of the palpebral fissure
时间窗: Eighteen months.
We will evaluate the change in palpebral fissure (unit of measure=millimetre)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.
次要结局
- Corneal topography(Eighteen months.)
研究者
Adimara da Candelaria Renesto
MD
Federal University of São Paulo