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临床试验/NCT00485199
NCT00485199已完成不适用

Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole

Peking University15 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
231
试验地点
15
主要终点
BCVA improvement,anatomic success

研究概览

简要总结

To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole.

详细描述

Retinal detachment caused by macular hole predominantly happened in high myopic eyes. This is a common type of retinal detachment in Asia and often seen in the old people aged around 50 ~ 60, mainly in female. Treatment of retinal detachment due to macular holes has changed over the years, and several methods have been described. Some surgeons have used transscleral diathermy or cryotherapy or laser photocoagulation and drainage subretinal fluid without sclera buckling, other surgeons have used radial silicone explants beneath the macular combined with cryo, diathermy or laser. This method entails the difficulty of placing sclera sutures far posterior, especially hazardous if there is a posterior staphyloma with very thin sclera. Besides the technically difficult, the extensive macular scarring caused by different coagulations limited the functional result to peripheral vision only. Because of this, it is not generally used in the initial treatment.

In 1982, Gonvers and Machemer4 proposed a new treatment technique that combined pars plana vitrectomy (PPV), partial air-fluid exchange, and face down positioning for 24 hours. Since then vitrectomy with gas tamponade become the most common procedure for retinal detachment with macular hole.

In 1984, Miyake performed a simple gas injection into the vitreous followed by a face-down position. The effective of this simplified method was then reported by many observers.But these studies may have insufficiency because of small sample, nonrandomized, no defined eligibility criteria for patients selection.

Intraocular gas tamponade with or without pars plana vitrectomy (PPV) has commonly been performed nowadays. We conducted a multicenter randomized controlled clinical trial to compare their anatomic results and visual outcomes of both surgical techniques, to estimate the efficiency of both surgical methods in the treatment of retinal detachment with myopic macular hole.

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
Single

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

入选标准

  • retinal detachment due to myopic macular hole.
  • The ability to give informed consent and to return for follow-up visit for 12 months

排除标准

  • retinal detachment with macular hole and peripheral hole/tear
  • retinal detachment with severe proliferative vitreoretinopathy
  • retinal detachment with choroidal detachment or rupture
  • traction retinal detachment due to retinal vascular disease
  • had vitrectomy in the past
  • macular hole without retinal detachment
  • foveal schiesis without retinal detachment
  • secondary macular hole with retinal detachment

结局指标

主要结局

BCVA improvement,anatomic success

时间窗: 1,3,6,9, and 12 months after treatment

次要结局

  • complication(1,3,6,9, 12 months after treatment)
  • costs of treatment(right after the treatment)

研究者

发起方
Peking University
申办方类型
Other

研究点 (15)

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