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临床试验/NCT04624035
NCT04624035Unknown不适用

Comparison Between Implantable Phakic Intraocular Lens and Implantable Collamer Lens in Treatment of Myopia in Adults

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud F. Rateb

Associate professor of ophthalmology

Assiut University

研究点 (2)

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