跳至主要内容
临床试验/NCT01280214
NCT01280214Unknown不适用

Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy

HaEmek Medical Center, Israel0 个研究点目标入组 30 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
主要终点
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy .

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Triamcinolone

Experimental

干预措施: Triamcinolone (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • To check if the level of TSH Receptor antibodies are affected by the local injection.(4 months)

研究者

申办方类型
Other

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