NCT05529589Unknown不适用
Comparative Study of Anti-VEGF Effect and Visual Function in Vitreous Hemorrhage Patients With Diabetic Macular Edema After Pars Plana Vitrectomy With Inner Limiting Membrane Peeling or Not
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Thickness change of retinal macular area
研究概览
简要总结
This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery
排除标准
- •The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region
- •The patient with a history of anti-VEGF therapy
- •Patients with DME in the contralateral eye requiring anti-VEGF therapy
- •Patients with contraindications of vitreous cavity resection
- •The patient has a history of intraocular surgery
- •The patient has active inflammatory disease
- •The patient has other retinal diseases that affect vision
- •The patient has other systemic diseases that required treatment with anti-VEGF drugs
- •Patient with contraindications to anti-VEGF therapy
结局指标
主要结局
Thickness change of retinal macular area
时间窗: 12 months
measurement of thickness of retinal macular area with macular optical coherence tomography after operation (0 day, 1 week, 1 months, 3 months, 6 months, 12 months)
Change of visual acuity
时间窗: 12 months
measurement of distance visual acuity with subjective refraction after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
次要结局
- B-mode ultrasound imaging(12 months)
- Change of eye pressure(12 months)
研究者
研究点 (1)
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