Comparison Between Implantable Phakic Intraocular Lens and Implantable Collamer Lens in Treatment of Myopia in Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual outcome
研究概览
简要总结
Phakic intraocular lenses (pIOL) of different designs and materials have been used effectively instead of corneal refractive surgery in certain situations. The pIOL exhibits a number of advantages over corneal techniques as it is suitable for high myopes, with lower production of aberrations, and superior contrast sensitivity. Keeping the accommodation is its definite lead over refractive lens exchange. The Visian implantable collamer lens (ICL; Staar Surgical, Monrovia, CA), a posterior chamber pIOL, has been stated to be useful for the correction of high myopia. Nevertheless, as an intraocular procedure, it is associated with a risk of complications as probable injury to anterior segment, retinal detachment and endophthalmitis.
The Implantable Phakic Contact Lens (IPCL V2, Caregroup Sight Solutions, India) has been developed as an alternative for the ICL, at a noticeable financial advantage. Furthermore, the highestmyopic correction which is instantly accessible with ICL is -18.0 D. Meanwhile, IPCL can provide correction higher degrees up to -30.0 D.
Former researches have been made to assess the safety and efficiency of ICL implantation, to evaluate various devices for anterior segment imaging postoperatively and to identify changes in anterior segment after surgery. A recent study determined the safety of the IPCL over a minimum follow-up period of one year. In this work the investigators aimed to compare the refractive results and the adverse effects of the IPCL and the ICL in treatment of myopia in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •myopia of more than 6 diopter
- •central anterior chamber depth more than 2.8 mm
排除标准
- •unstable refraction
- •any other ocular disease
- •any systemic disease
结局指标
主要结局
Visual outcome
时间窗: 12 months
Uncorrected distance and near vision using Snellen's chart and using decimal fractions
Refractive outcome
时间窗: 12 months
Postoperative refractive error measured in spherical equivalent
次要结局
- Adverse reactions(12 months)
研究者
Mahmoud F. Rateb
Associate professor of ophthalmology
Assiut University
