Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Retinal microvessels density
研究概览
简要总结
To observe the retinal microvascular alteration during 3 months follow-up after Implantable Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (OCTA) analysis.
详细描述
The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was used to image the superficial and deep retinal vascular plexuses before ICL implantation surgery and at 3 months follow-up. OCTA images were corrected for magnification, skeletonized, separated the large vessels and partitioned. Retinal microvascular density was measured by using fractal dimension analysis. The aim of this study was to uncover potential retinal vascular network alterations induced by ICL implantation surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 45 years old;
- •Binocular myopia, with a refraction of greater than -3 diopters (D);
- •anterior chamber depth (ACD, measured from the endothelium to the crystalline lens) > 2.8 mm;
- •corneal endothelial cell count (cECC) ≥ 2000 cells/mm2;
- •stable refraction at least 1 year before surgery;
- •unsatisfactory vision with contact lenses or spectacles.
排除标准
- •history of intraocular surgery
- •other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye, etc.)
- •other serious systemic disease (diabetes, uncontrolled hypertension, severe hyperthyroidism, etc.).
结局指标
主要结局
Retinal microvessels density
时间窗: 3 months postoperatively
Retinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)
次要结局
- Intraocular pressure(3 months postoperatively)
- Vault(3 months postoperatively)
- Best corrected visual acuity(3 months postoperatively)
- Mean refractive spherical equivalent(3 months postoperatively)