University Hospital of Endocrinology
Sofia, 1000, Bulgaria
NCT Number: NCT05775185
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.
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Notify Me18 year and older
All sexes
Observational
Sofia, 1000, Bulgaria
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:
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.
Time frame: 12 months
Effect on therapeutic response and individual ocular parameters
Time frame: 12 months
Effect of orbital radiotherapy on disease-specific quality of life
Medical University of Sofia
Other
Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy
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