Comparative evaluation of clinical outcomes of toric Implantabe Contact Lens (ICL) versus toric Implantable Phakic Contact lens (IPCL)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Postoperative emmetropia
研究概览
简要总结
This is a prospective, randomized study designed to compare two types of phakic lenses; the toric ICL and the toric IPCL. The study will involve 40 eyes with high myopia with regular corneal astigmatism more than 1.25 D. These will be randomly allocated in 2 groups based on computer generated random number table. Group 1 will include 20 eyes which will undergo toric ICL implantation while Group 2 will include 20 eyes which will include 20 eyes which will undergo toric IPCL implantation. Parameters which will be assessed include uncorrected and best corrected visual acuity, keratometric and refractive cylinder, endothelial cell count, intraocular pressure, higher order aberrations, lens rotation, contrast sensitivity and glare acuity. All these investigations will be performed at baseline, 1 week, 1 month, 3 months and at 6 months follow up visit.
ii.
x.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •40 eyes, with high myopia and regular corneal astigmatism more than 1.25 D.
排除标准
- •a) Presence of other associated ocular co-morbidities such as glaucoma, uveitis, or any posterior segment pathology.
- •b) Patients with irregular corneal astigmatism due to corneal scarring or other corneal abnormalities c) Patient not willing to participate or follow up in the study.
结局指标
主要结局
1. Postoperative emmetropia
时间窗: Baseline, 1 week, 1 month, 3 months and at 6 months
2. Phakic lens stability
时间窗: Baseline, 1 week, 1 month, 3 months and at 6 months
次要结局
- 1. Post operative higher order aberrations(2. Contrast sensitivity and glare acuity)