Comparison Between Toric and Spherical Implantable Collamer Lens Combined With Astigmatic Keratotomy for High Myopic Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- astigmatism
研究概览
简要总结
To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ranged from 18 to 40 years,
- •myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D,
- •for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree,
- •a stable refractive error during the previous 2 years,
- •anterior chamber depth more than 2.8 mm,
- •endothelial cell density (ECD) more than 2500 cells/mm2, and
- •scotopic pupillary diameter less than 7 mm.
排除标准
- •subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.
研究组 & 干预措施
Toric Implantable Collamer Lens
Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism
干预措施: Toric Implantable Collamer Lens (Device)
ICL+ Astigmatic keratotomy
Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism
干预措施: ICL + Astigmatic keratotomy (Device)
结局指标
主要结局
astigmatism
时间窗: 2 years after surgery
astigmatism getting from subjective refraction
Uncorrected Visual Acuity (UCVA) at distance
时间窗: 2 years after surgery
measured at 5 meter
次要结局
- mean postoperative UCVA/mean preoperative BCVA(2 years after surgery)
- Best Corrected Visual Acuity (BCVA) at distance(2 years after surgery)
- Spherical Equivalent (SE)(2 years after surgery)
- mean postoperative BCVA/mean preoperative BCVA(2 years after surgery)
研究者
A-Yong Yu
vice director of refractive surgery department of the eye hospital of WZMU
Wenzhou Medical University