Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography
研究概览
简要总结
Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 18 years of older
- •Signing of informed consent
- •Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)
排除标准
- •Diagnosis of glaucoma
- •Known allergy to brilliant blue G
研究组 & 干预措施
Double staining with brilliant blue G during vitrectomy
干预措施: brilliant blue G (Drug)
结局指标
主要结局
Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography
时间窗: 6 months
Average thickness of ganglion cell layer - inner plexiform layer measured by spectral domain optical coherence tomography
Amplitude of b-wave of multifocal electroretinogram
时间窗: 6 months
Measurement of the amplitude of the b-wave of multifocal electroretinogram
Amplitude of pattern reversal electroretinogram
时间窗: 6 months
Amplitude of pattern reversal electroretinogram (in microvolts)
次要结局
- Visual acuity(6 months)
- Complications(6 months)