Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery
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
Lin Lu
Director, Fundus Disease Center of Zhongshan Ophthalmic Center
Sun Yat-sen University
