NCT01509092已完成不适用
Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- macular hole closure rate
研究概览
简要总结
The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.
详细描述
Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •closed globe injury
- •identification of full-thickness macular hole by optical coherence tomography within one month after trauma
排除标准
- •open globe injury
- •coexistence of idiopathic macular hole
- •severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)
- •combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)
- •coexistence of high myopia
- •coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400μm from the center of the foveola
- •coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)
结局指标
主要结局
macular hole closure rate
时间窗: 6 month after injury
次要结局
- central foveal thickness(6 month after hole closure)
- length of inner-segment outer-segment junction defect(6 month after hole closure)
- final visual acuity(6 month after hole closure)
研究者
Zhi-zhong Ma
Professor
Peking University Third Hospital
研究点 (8)
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