Local Triamcinolone Injection in Active Thyroid Orbitopathy

Not Applicable

• Conditions: Thyroid Disease
• Interventions: Drug: Triamcinolone

• Registration Number: NCT01280214
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.

Detailed Description

Local Steroid treatment may help in active thyroid orbitopathy. till today, systemic Steroids are the treatment for active thyroid orbitopathy which is associated with systemic adverse effects.

In this study the investigators want to compare the effectiveness of local Triamcinolone therapy for active thyroid orbitopathy.

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-01-15
• Study First Submitted QC: 2011-01-19
• Last Update Submitted: 2011-01-19
• Study First Posted: 2011-01-20
• Last Update Posted: 2011-01-20
• Study Start: 2011-02
• Primary Completion: 2013-02
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age>18 years.
• Active thyroid orbitopathy according to clinical activity score>=3.

Exclusion Criteria

• Intraorbital or active infections.
• Tuberculosis.
• Other orbital disease.
• Pregnancy.
• Compressive optic neuropathy.
• Systemic steroid therapy within 6 months of study start.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triamcinolone	Triamcinolone	-

Primary Outcome Measures

Name	Time	Method
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy .	6 months	Every month, each participant will undergo several tests : blood sugar, full ocular examination, color test, visual field and ultrasound test for measuring the thickness of extraocular muscles.Clinical activity score for thyroid orbitopathy will be assesed too. The results of the clinical and ultrasonogrophic findings will determine the effectiveness of the treatment.; A patient with deterioration of thyroid orbitopathy during the research, will be treated by systemic Steroids in addition to the local injections.

Secondary Outcome Measures

Name	Time	Method
To check if the level of TSH Receptor antibodies are affected by the local injection.	4 months	A blood test for TSH Receptor antibodies will be taken for every patient at the beginnig of the research and after 4 months.