The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .
研究概览
简要总结
The purpose of this study is to determine whether combination of orbital compression surgery with strabismus surgery is better than strabismus surgery after orbital compression surgery in the treatment of moderate-to-severe thyroid associated ophthalmopathy
详细描述
This study will be a interventional case series. Patients with moderate-to-severe thyroid associated ophthalmopathy will be randomized to receive combination of orbital compression surgery with strabismus surgery or strabismus surgery after orbial compression surgery.Patients will be followed for 6 months.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-to-severe thyroid associate ophthalmopathy
- •CAS≤3 score
- •monocular strabismus,deviation≥20° or 35▲
- •stable thyroid function for at least 6 months, confirmed by an endocrinologist
排除标准
- •any previous disease in the study eye.
- •any previous systematic disease
结局指标
主要结局
quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .
时间窗: 6 weeks after surgery
All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = \[(raw score - 8)/16 9 100\]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = \[(raw score - \*)/(2x\*) x100\] where \* is the number of completed items.
quality of life, measured by GO-QoL(quality of life with Grave's Orbitopathy) .
时间窗: 6 months
All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = \[(raw score - 8)/16 9 100\]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = \[(raw score - \*)/(2x\*) x100\] where \* is the number of completed items.
次要结局
- strabismus status(6 months after surgery)
研究者
Huasheng Yang
Sun Yat-sen University
Sun Yat-sen University