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临床试验/NCT01297803
NCT01297803Unknown2 期

Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Mitomycin_c (Drug)

Mitomycin_c application after sclera flapdissection

Active Comparator

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)

研究者

研究点 (1)

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