NCT06588764招募中不适用
Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- best corrected visual acuity (BCVA)
研究概览
简要总结
To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.
详细描述
The purpose of the study is to evaluate the effectiveness and complications of modified deep lateral wall decompression and medial wall decompression, in order to develop a standardized technical approach to the treatment of Moderate-to-severe Grave's Ophthalmopathy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy;
- •CAS≤3 score;
- •stable thyroid function for at least 6 months;
- •able and willing to participate in clinical trials and ensure regular follow-up;
排除标准
- •any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
- •B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
- •uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases
- •those who were considered by the researchers to be excluded
结局指标
主要结局
best corrected visual acuity (BCVA)
时间窗: within 24 weeks of surgery
Using Snellen scale, decimal fraction
次要结局
- N75-p100 amplitude of PVEP(within 24 weeks of surgery)
- value of Hertel(within 24 weeks of surgery)
- the mean deviation value of visual field (VF)(24 weeks after surgery)
- pattern standard deviation value of visual field(within 24 weeks of surgery)
- the P100 latency of pattern visual evoked potential (PVEP)(within 24 weeks of surgery)
- clinical activity score (CAS)(within 24 weeks of surgery)
- volume of adipose tissue(during the surgery)
研究者
Huasheng Yang
Clinical Professor
Sun Yat-sen University
研究点 (1)
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