The Therapeutic Effect of Dysthyroid Optic Neuropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- BCVA
研究概览
简要总结
Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Dysthyroid optic neuropathy (DON) is the most serious complication of TAO, which can cause blurred vision, color vision and vision function damage, and affects the quality of life. Investigation of the therapeutic effect of orbital decompression may provide some clues to make the policy at treatment of DON. We explore the therapeutic effect of orbital decompression in patients with DON in both eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months
排除标准
- •With any serious systemic diseases With any surgery on eyes in six months
研究组 & 干预措施
Orbital decompression combined MPT
Orbital decompression was performed by the same doctor with rich clinical experience. MPT should be implemented in the patients with obvious thyroid disorder before orbital decompression surgery which should only be performed when thyroid function was stabilized. The surgery was performed under general anesthesia. An arcuate incision was made in the skin 2 mm below the lower eyelid margin, and the tissue under the incision were separated to the periorbita and orbital septum. Part of the medial orbital wall, inferior orbital wall and partial tissue of ethmoidal sinus were removed, and an appropriate amount of adipose tissue was excised. MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced.
干预措施: Orbital decompression combined with MPT (Procedure)
Separate MPT
MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced.
干预措施: Orbital decompression combined with MPT (Procedure)
结局指标
主要结局
BCVA
时间窗: 6 months
best corrected visual acuity in logMAR
IOP
时间窗: 6 months
intraocular pressure in mmHg
proptosis
时间窗: 6 months
proptosis in mm
upper eyelid retraction
时间窗: 6 months
upper eyelid retraction in mm
CAS
时间窗: 6 months
clinical activity score
次要结局
- MD(6 months)
- PSD(6 months)
研究者
Huasheng Yang
Clinical Professor
Sun Yat-sen University