Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Graves Ophthalmopathy
- Sponsor
- Medical University of Sofia
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Efficacy of orbital radiotherapy
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Mariya Stoynova
Principal investigator
Medical University of Sofia
Eligibility Criteria
Inclusion Criteria
- •Active moderate-to-severe Graves' orbitopathy
Exclusion Criteria
- •Contraindications for orbital radiotherapy
Outcomes
Primary Outcomes
Efficacy of orbital radiotherapy
Time Frame: 12 months
Effect on therapeutic response and individual ocular parameters
Effect of orbital radiotherapy on quality of life
Time Frame: 12 months
Effect of orbital radiotherapy on disease-specific quality of life