Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Efficacy of orbital radiotherapy
研究概览
简要总结
The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:
- How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
- How does the quality of life changes after orbital radiotherapy?
Participants have active moderate-to-severe Graves' orbitopathy and are treated with low dose fractionated orbital radiotherapy for two weeks. During the follow-up period they undergo regular ocular examinations and fill out a disease-specific questionnaire.
详细描述
Orbital radiotherapy is a well-established second-line therapy for moderate-to-severe forms of Graves' orbitopathy. However, the question about it efficacy is still controversial. The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:
- How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
- How does the quality of life changes after orbital radiotherapy?
Participants have active moderate-to-severe Graves' orbitopathy untreated or already treated with systemic glucocorticoids and are referred to low dose fractionated orbital radiotherapy, total dose 20 Gy divided into 10 sessions, 2 Gy for each session. A concomitant intake of low-dose glucocorticoids is prescribed to all patient. During the follow-up period they undergo regular ocular examinations (at 1st, 3rd, 6th and 12th month), which includes comprehensive ocular status, hormonal and immunological testing and evaluation of the current therapeutic response. The patients also fill out a disease-specific questionnaire (at 3rd, 6th and 12th months).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active moderate-to-severe Graves' orbitopathy
排除标准
- •Contraindications for orbital radiotherapy
结局指标
主要结局
Efficacy of orbital radiotherapy
时间窗: 12 months
Effect on therapeutic response and individual ocular parameters
Effect of orbital radiotherapy on quality of life
时间窗: 12 months
Effect of orbital radiotherapy on disease-specific quality of life
次要结局
未报告次要终点
研究者
Mariya Stoynova
Principal investigator
Medical University of Sofia
