Local Triamcinolone Injection in Active Thyroid Orbitopathy
Recruitment status was: Not yet recruiting
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy|
- Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy . [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
- To check if the level of TSH Receptor antibodies are affected by the local injection. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]A blood test for TSH Receptor antibodies will be taken for every patient at the beginnig of the research and after 4 months.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
Other Name: kenalog
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280214
|Study Chair:||Daniel Briscoe, MD||haemek medical center|