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临床试验/NCT03586193
NCT03586193Unknown不适用

Application of Pars Plana Vitrectomy in the Treatment of Macular Schisis in High Myopic Eyes

Aier School of Ophthalmology, Central South University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
The morphologic change of macular area

研究概览

简要总结

High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.
  • Morphologic manifestation in OCT shows split between retinal layers in macular area.
  • Patients without severe systemic disease and can tolerate surgery.

排除标准

  • Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.
  • Patients with nystagmus or have difficult to open the eye.
  • Patients with severe systemic disease and cannot tolerate surgery.

结局指标

主要结局

The morphologic change of macular area

时间窗: OCT will be done one day before surgery and one week, one month, three months and six months after surgery

The thickness of the macular fovea in optical coherence tomography (OCT)

次要结局

  • The best corrected visual acuity (BCVA) change(One day before surgery and one week, one month, three months and six months after surgery)
  • The best corrected near visual acuity (BCNVA) change(One day before surgery and one week, one month, three months and six months after surgery)
  • The visual function change(One day before surgery and one week, one month, three months and six months after surgery)

研究者

发起方
Aier School of Ophthalmology, Central South University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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