NCT05627401招募中不适用
Customized Modified Multiple Orbital Wall Decompression With Fat Removal for Sight-threatening Graves's Ophthalmopathy : a Retrospective Cohort Study
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- EVP
研究概览
简要总结
Graves' orbitopathy (GO) is an disfiguring and disabling autoimmune condition. Sight-threatening GO is an most severe form and occurs in about 5% of patients with Graves' disease. It can cause blurred vision, color vision and vision function damage, and affects the quality of life. The goal of this retrospective cohort study is to propose a customized orbital decompression algorithm for patients with sight-threatening Graves'ophthalmopathy and to explore the therapeutic effect of customized orbital decompression in sight-threatening patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sight-threatening patients undergoing interdisciplinary discussion and orbital decompression operation.
- •The sight-threatening GO refer to those with DON, exposure keratitis or corneal breakdown.
- •DON was diagnosed according to the following clinical findings including optic nerve head edema, visual field defect, impaired color vision, afferent pupil defect, retinal folds, radiologic evidence of apical optic nerve compression or globe subluxation.
- •Diagnosis of exposure keratitis or corneal breakdown was made based on physical exam signs, e.g. microepithelial defects, abrasion or ulcer. A minimum follow-up of 12 months was required for inclusion.
排除标准
- •Patients were excluded if exophthalmos, rather than acute visual loss, was the indication for surgery.
- •Cases with a history of previous ocular surgery, glaucoma, and visual defects from other ocular conditions were excluded from the study.
结局指标
主要结局
EVP
时间窗: 12 months
Visual Evoked Potential
proptosis
时间窗: 12 months
proptosis in mm
CAS
时间窗: 12 months
clinical activity score
BCVA
时间窗: 12 months
best corrected visual acuity in logMAR
次要结局
- GO-QOL(12 months)
研究者
研究点 (1)
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