Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection
试验速览
- 阶段
- 2 期
- 试验地点
- 1
- 主要终点
- corneal endothelial cell density
研究概览
简要总结
Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Range between 18 to 80 years old
- •Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.
排除标准
- •Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).
研究组 & 干预措施
Mitomycin_c application before sclera flap dissection
干预措施: Mitomycin_c (Drug)
Mitomycin_c application after sclera flapdissection
干预措施: Mitomycin_c (Drug)
结局指标
主要结局
corneal endothelial cell density
时间窗: six month
specular microscopy
corneal endothelial cell polymorphism
时间窗: 6 months
specular microscopy
corneal endothelial cell polymegathism
时间窗: 6 months
specular microscopy
次要结局
- IOP (intra ocular pressure)(six months)
