Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy
NCT ID: NCT00004660
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
1993-06-30
1998-01-31
Brief Summary
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II. Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6 months later in the course of the disease produces effects of equal magnitude to those observed when the first orbit was treated.
III. Relate the magnitude of treatment effects to the time since onset of eye symptoms.
IV. Evaluate whether characteristics of radiation retinopathy are present 3 years after orbital radiotherapy.
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Detailed Description
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The untreated eye receives a simultaneous sham treatment during each radiotherapy session.
Patients are followed at 3, 6, 9, 12, and 36 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Radiotherapy
Radiotherapy
Sham treatment
Sham treatment
Interventions
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Radiotherapy
Sham treatment
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics-- Firm diagnosis of Graves' disease with normal thyroid function, i.e.: Thyroid-stimulating immunoglobulin positive Thyroxine 5-12.5 micrograms/dL Tri-iodothyronine 80-180 nanograms/dL Thyroid-stimulating hormone 0.2-8 milli-International unit (mIU/L) Euthyroid due to therapy acceptable Ophthalmopathy meeting at least 3 of the following criteria: Chemosis or lid edema Lid lag, lid retraction, or restrictive lagophthalmos Proptosis at least 20 mm by Krahn exophthalmometry in at least 1 eye Less than 4 mm discrepancy between eyes Patient perception of "stare" or "bulge" Extraocular muscle motion restriction in 1 or both eyes on clinical exam or by patient report of diplopia at extremes of gaze Extraocular muscle enlargement on computerized tomography (previous study results acceptable) Mild to moderate ophthalmopathy, i.e.: Orbital pain Lacrimation Photophobia Visual blurring or diplopia No optic neuropathy, i.e.: Afferent pupillary defect Impaired color vision on D-15 testing (unless congenital color perception deficiency) Visual field defect Impaired visual acuity No corneal ulcers --Prior/Concurrent Therapy-- No prior external-beam radiotherapy to the head and neck At least 2 weeks since corticosteroids --Patient Characteristics-- No prior head and neck tumors No diabetes No pregnant women
30 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Colum A. Gorman
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Gorman CA, Garrity JA, Fatourechi V, Bahn RS, Petersen IA, Stafford SL, Earle JD, Forbes GS, Kline RW, Bergstralh EJ, Offord KP, Rademacher DM, Stanley NM, Bartley GB. A prospective, randomized, double-blind, placebo-controlled study of orbital radiotherapy for Graves' ophthalmopathy. Ophthalmology. 2001 Sep;108(9):1523-34. doi: 10.1016/s0161-6420(01)00632-7.
Other Identifiers
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MAYOC-1889200
Identifier Type: OTHER
Identifier Source: secondary_id
199/11860
Identifier Type: -
Identifier Source: org_study_id
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