跳至主要内容
临床试验/NCT02915133
NCT02915133暂停不适用

Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
20
试验地点
1
主要终点
change from baseline OCT at 6 months

研究概览

简要总结

Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT) is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an objective examination for visual evaluation. To our knowledge, there is a lack of data on the comprehensive visual function evaluations of MF patients associated with OCT findings. Our clinical trial aims to provide the structural and functional relationship in MF patients undergoing MB surgery, and find out potential factors to determine the visual prognosis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • •axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;
  • •macular foveoschisis that requires surgical intervention.

排除标准

  • •ocular trauma or surgery history;
  • •glaucoma, diabetic retinopathy;
  • •intraocular active hemorrhage or inflammation;
  • •unable to coordinate the OCT, mfERG, or other ophthalmological examinations.

结局指标

主要结局

change from baseline OCT at 6 months

时间窗: 6 month postoperatively

change from multifocal ERG at 6 months

时间窗: 6 month postoperatively

次要结局

  • change from Best-corrected visual acuity (BCVA) at 6 months(6 month postoperatively)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin Lu

Director, Fundus Disease Center of Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

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