Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Number of Severe PVR
研究概览
简要总结
Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients; to prove the percentage of PVR-IC decides the risk of serious PVR occurring after surgery; to investigate the safety and efficacy of early local steroids drug intervention in patients with severe postoperative PVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age: 18-60 years old, regardless of gender; (2) Clinical diagnosis of with rhegmatogenic retinal detachment (RRD); (3) Surgery for Retinal Detachment is required; (4) Myopia < = 800 degrees; (4) PVR classification: no restrictions; (5) Patients undergoing the first or second operation. (6) Patients volunteered to participate in this study and signed informed consent.
排除标准
- •(1) Exudative detachment of retina; (2) Those who are allergic to the drugs used in the study; (3) Combined with other eye diseases: other fundus diseases, glaucoma, corneal opacity diseases, genetic diseases); (4) history of internal eye surgery >=3 times; (5) Postoperative follow-up could not be scheduled; (6) Patients with systemic diseases (such as asthma, heart failure, myocardial infarction, liver failure, kidney failure and other major diseases).
结局指标
主要结局
Number of Severe PVR
时间窗: 3 months post operation
Number of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed proliferative band height exceeded 0mm, OCT showed proliferative band exceeded 0um)
Best Corrected visual Acuity (BCVA）
时间窗: 3 months post operation
Patients' best corrected visual acuity assessed by logarithmic visual acuity(0.5-1.0； For example, normal vision was 1.0)
Intraocular pressure (IOP)
时间窗: 3 months post operation
Patients' IOP(mmHg) assessed by noncontact tonometer
Retina reattachment rate
时间窗: 3 months post operation
Percentage of participants whose fundus achieved the following conditions simultaneously (B-mode ultrasound showed retinal detachment band height was 0mm, OCT showed subretinal fluid height was 0um)
次要结局
- Retina reattachment rate(12 months post operation)
- Best Corrected visual Acuity (BCVA）(12 months post operation)
- Intraocular pressure (IOP)(12 months post operation)
- Number of Severe PVR(12 months post operation)
研究者
Fang Wang
Chief of department of ophthalmology
Shanghai 10th People's Hospital