Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery
试验速览
- 阶段
- 2 期
- 试验地点
- 1
- 主要终点
- BCVA
研究概览
简要总结
This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .
Process of degeneration begins from first hours of RD (Retinal Detachment) establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .
How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researcher.
In the study the investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 8 years old
- •gender of both sex
- •normal liver and renal function
- •informed consent received from all patients
- •no pregnancy and no lactation
- •minimal sun exposure
排除标准
- •diabetic retina
- •previous retinal surgery CRF& liver disfunction RD + PVR > B Hyper sensitivity to tetracycline History previous MPC or PRP Patients unsuccessful SB (retina is off )
研究组 & 干预措施
placebo
100mg-
干预措施: placebo (Drug)
minocyclin
干预措施: Minocycline (Drug)
结局指标
主要结局
BCVA
时间窗: changes of BCVA in 3 month
outcome method of measurement: Snellen chart
次要结局
- finding of ERG changes(3 months)
- finding of OCT changes(3 months)
- finding of FAF changes(3 months)