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临床试验/NCT00000154
NCT00000154已完成3 期

Diabetic Retinopathy Vitrectomy Study (DRVS)

National Eye Institute (NEI)0 个研究点开始时间: 1999年9月24日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成

研究概览

简要总结

To compare two therapies, early vitrectomy and conventional management, for recent severe vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if retinal detachment involving the center of the macula develops at any time.

To compare early vitrectomy and conventional management in eyes that have good vision but a poor prognosis because they are threatened with hemorrhage or retinal detachment from very severe proliferative retinopathy.

To study the natural history of severe proliferative diabetic retinopathy.

详细描述

Vitrectomy may not only remove vitreous hemorrhage but also prevent or relieve traction on the retina from contraction of the fibrovascular membranes that characterize severe proliferative diabetic retinopathy. It is important to determine whether early intervention with vitrectomy has a better visual outcome or instead produces a rate of serious complications higher than the rate associated with conventional management.

Two randomized trials were carried out in the DRVS among patients ages 18 to 70 years who had either insulin-dependent or non-insulin-dependent diabetes. In the first trial, the 616 patients who were recruited had severe visual loss from recent severe vitreous hemorrhage in at least one eye. Eligible eyes were randomly assigned either to early vitrectomy or to conventional management. In the conventional management group, vitrectomy was carried out 1 year later if hemorrhage persisted; vitrectomy was carried out sooner if retinal detachment -involving the center of the macula occurred.

In the second trial, 381 patients were recruited, all of whom had severe fibrovascular proliferations and useful vision in at least one eye. Eligible eyes were assigned either to early vitrectomy or to conventional management. Conventional management included photocoagulation when indicated, with vitrectomy if a severe vitreous hemorrhage occurred and failed to clear spontaneously during a 6-month waiting period or if retinal detachment involving the center of the macula -occurred. After randomization and treatment, all patients were examined at 6-month intervals for 2 years and annually thereafter. Comparisons of visual acuity distributions between experimental and control groups were made.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

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