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Prospective Clinical Case-control Study of Selenium treatment for mild to moderate Graves ophthalmopathy

Prospective Clinical Case-control Study of Selenium treatment for mild to moderate Graves ophthalmop

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15005855
Enrollment
Unknown
Registered
2014-10-11
Start date
2014-10-20
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild to moderate Graves ophthalmopathy

Interventions

A:Selenium treatment

Sponsors

1st affiliated hospital of China medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a history of Graves' hyperthyroidism, who have been rendered euthyroid for at least 2 months by antithyroid drugs, or surgery. If 131-Iodine is used, at least 6 months should lapse before recruitment. Euthyroidism is defined as normal serum free T4, and normal free T3 or total T3 levels, in the absence of an elevated serum TSH concentration. All patients should remain euthyroid during the duration of the 6 study, and no thyroid surgery or treatment with 131I should be given. Patients should not be treated with systemic steroids, orbital radiotherapy or any other specific medication or surgical treatment for their eye disease during the study, unless the deteriorates; 2. Patients should at least have one sign of Graves' ophthalmopathy, with a disease duration of less than 18 months (as recorded by the patient); 3. The ophthalmopathy has not been treated in the past by any means, except for local measures (e.g. eye drops); 4. Age 18-65 years.

Exclusion criteria

Exclusion criteria: 1. Soft tissue swelling NO SPECS class 2.c (e.g. severe chemosis, severe eye lid swelling) according to the Color Atlas; 2. Proptosis of more than 22 mm; 3. Diplopia in primary or reading position, and/or ocular torticollis; 4. Mono-ocular duction in any direction of less than 20 degrees; 5. Signs or symptoms of optic nerve involvement; 6. Pregnant or planning pregnancy, or in lactating; 7. History of alcoholism or drug abuse; 8. Have severe concomitant diseases, such as liver, renal insufficiency, diabetes mellitus, other systemic autoimmune diseases; 9. Can not always carry out the test; not been informed consent.

Design outcomes

Primary

MeasureTime frame
thyrotropin;Free thyroxine;serum Selenium;Thyrotropin receptor antibody;Glutathione peroxidase;vision;exophthalmos;intraocular tension;Eyelid measurement;Soft tissue infiltration;

Countries

China

Contacts

Public ContactYushu Li
sss2788@163.com+86 24 83282152

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026