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临床试验/NCT05775185
NCT05775185已完成不适用

Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy

Medical University of Sofia1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年7月25日最近更新:
适应症

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:

  1. How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
  2. 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:

  1. How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
  2. 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

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

发起方
Medical University of Sofia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariya Stoynova

Principal investigator

Medical University of Sofia

研究点 (1)

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