A Multi-model Image of Immunosuppressive Agents in Thyroid Associated Ophthalmopathy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- change of macular sensibility
研究概览
简要总结
This study aims to evaluate the efficacy of immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model image.
详细描述
Thyroid Associated Ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. TAO can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. A great number of patients in inactive phase becoming refractory and reoccurring.
Until now, the improvement of TAO is still be measured subjectively with low reliability and less accuracy. Multi-modal image is a new method to assess both the appearance and visual function of TAO and some of the indexes can be regarded as more apparent and stable in assessing the efficacy and prognosis of TAO.
This perspective cohort study aims to evaluate the efficacy of immunosuppressive agents in TAO by multi-model image and function assessments.
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
盲法说明
Assessors who calculate the changes of the images are masked of the diagnosis and treatment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 18-70 years old
- •Diagnosed with TAO.
排除标准
- •Contraindications to immunosuppressive agents.
- •Patients with HIV, Hepatitis B or C, Tuberculosis or other active significant infection.
- •Patients with severe chronic diseases in heart, lung, kidney and liver, which make it not tolerant to immunosuppressive agents.
- •Patients have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination).
研究组 & 干预措施
immunosuppressive agents
patients recruited will be treated with one or／and two immnuosuppressive agents
干预措施: immunosuppressive agent (Drug)
结局指标
主要结局
change of macular sensibility
时间窗: At 6 months
the same investigator uses the same instrument to assess the macular sensibility. The better change of macular sensibility means the better outcome.
次要结局
- change of extraocular muscle volume and orbital fat volume by MRI(at month 6)
- change of QoL(at month 6)
- change of eyelid aperture and lid lag(at month 6)
- change of proptosis(at month 6)
研究者
Dan Liang
Dan Liang, PhD
Sun Yat-sen University