Graves' Ophthalmopathy Clinical Trial
The relationship between the method of the treatment of hyperthyroidism due to Graves'
disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to
compare the results of total thyroidectomy done in 6 months following the appearance of the
symptoms of ophthalmopathy and the antithyroid drug therapy in patients with moderate to
severe Graves' ophthalmopathy.
The inclusion criteria: 1)Hyperthyroidism and moderate to severe Graves' ophthalmopathy
within 6 months, 2)Thyroid volumes greater than or equal to 15 mL in thyroid
ultrasonography, 3)Patients taking no treatment except local medications for Graves'
ophthalmopathy, 4)Clinical activity score of 3/7 or more, proptosis greater than or equal to
21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of
the eye lid greater than or equal to 9 mm.
All patients will be treated with antithyroid drug until TSH levels of the patients are
between 0.4-1. During this period all the patients will take pulse methyl prednisolone
treatment of a total dose of 4.5 gr. After pulse steroid treatment the patients will be
randomised to two groups: one group will be sent to surgery for total thyroidectomy, and
their TSH levels will be kept between 0.4-1 with levothyroxine treatment; the other group
will be followed under antithyroid drug treatment and their TSH levels will be kept between
0.4-1 also.
The smoking habits will be asked. Serum TSH, fT4 levels, Hertelmeter and eye lid opening
measurements, clinical activity scores, diplopia will be evaluated monthly; TSH receptor
antibody, anti-thyroid peroxidase and anti-thyroglobulin levels will be measured in 3 months
intervals for a period of 12 months.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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