A Multi-model Image to Evaluate the Efficacy of Doxycycline 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
- 20
- 试验地点
- 1
- 主要终点
- change of extraocular muscle volume and orbital fat volume by MRI
研究概览
简要总结
This study aims to evaluate the efficacy of doxycycline treating Thyroid Associated Ophthalmopathy by multi-modal 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. Different degrees of exophthalmos, eyelid aperture, lid retraction and lid lag are common symptoms apprearing in TAO. The improvement of exophthalmos is usually measured with Hertel instrument and the change of eyelid is measured with millimeter ruler. All these measurements are subjective, low reliable and less accurate.
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. But still a progression and reoccurrence can be a big challenge for ophthalmologists. This is a perspective cohort study to evaluate the efficacy of doxycycline in TAO by multi-model image.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Sight-threatening TAO with dysthyroid optic neuropathy
- •Allergy of tetracycline
- •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
doxycycline
patients administrated with doxycycline tablets 100mg orally per day
干预措施: Doxycycline Hyclate (Drug)
结局指标
主要结局
change of extraocular muscle volume and orbital fat volume by MRI
时间窗: at month 6
3D MRI image will be established and the volume of extraocular muscle and orbital fat will be calculated by the same advanced programmer who is blinded of the pre- or post- treatment images order. A higher score means a better outcome.
次要结局
- change of exophthalmos(at month 6)
- change of eyelid aperture, lid retraction and lid lag(at month 6)
- change of Quality of Life(at month 6)
研究者
Dan Liang
principal investigator
Sun Yat-sen University