跳至主要内容
临床试验/NCT00556244
NCT00556244Unknown1 期

Pars Plana Vitrectomy for Diabetic Fibrovascular Proliferation With and Without Internal Limiting Membrane Peeling

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
1 期
入组人数
40
试验地点
1
主要终点
Snellen BCVA and epiretinal membrane formation measured with OCT

研究概览

简要总结

Internal limiting membrane peeling in diabetic vitrectomy will help prevent postoperative epiretinal membrane formation

详细描述

Progressive fibrovascular proliferation may occur despite appropriate panretinal photocoagulation in diabetic patients. Fibrovascular proliferation may lead to persistent or recurrent vitreous hemorrhage, macular traction, or traction macular detachment, and becomes a major indication for vitrectomy.1 During the past 25 years, anatomical and visual results of vitrectomy for severe proliferative diabetic retinopathy have improved as a result of improved understanding of the pathoanatomy and improvements in surgical instrumentation.2-5 Although anatomical success is high after complete vitrectomy, recurrent epiretinal membrane may cause macular thickening, cysts formation, preventing good functional outcome.6 An epiretinal membrane (ERM) is a non-vascular cellular membrane that may cause symptomatic visual disturbances due to retinal wrinkling and distortion.7 These epiretinal membranes have been found to be composed of fibroblasts, glial cells, macrophages, myofiboblasts, nad retinal pigment epithelial cells.8-9 Studies have suggested removal of internal limiting membrane (ILM) may decrease the likelihood of post-operative ERM formation in cases of diabetic macular edema and idiopathic ERM. It is postulated that removal of the ILM removes the scaffold upon which myofibroblasts would proliferate.10 Efficacy of vitrectomy including removal of ILM was mostly described as facilitating resolution of diffuse diabetic macular edema11 and improvement of visual acuity or in macular hole surgery in diabetic patients.12However, it is unknown if removal of ILM during vitreoretinal surgery in diabetic patients with active fibrovascular proliferation is useful in preventing postoperative ERM formation. The purpose of this study is to compare the postoperative epiretinal membrane (ERM) formation and visual outcome in diabetic patients with active fibrovascular proliferation who underwent vitrectomy with or without ILM peeling.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • active fibrovascular proliferation with or without tractional detachment
  • previous pan-retinal photocoagulation at least 3 months before

排除标准

  • biomicroscopic evidence of macular hole
  • combination of tractional and rhegmatogenous retinal detachment
  • location of fibrovascular proliferation anterior to the equator
  • major ocular surgery history(including, scleral buckle, glaucoma filter, cornea transplant, vitreoretinal surgery etc
  • the presence of other ocular conditions such as glaucoma, uveitis, or other ocular inflammatory diseases.

结局指标

主要结局

Snellen BCVA and epiretinal membrane formation measured with OCT

时间窗: within 6 months after the surgery

次要结局

  • central macular thickness measured bt OCT(within 6 months after the surgery)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验