跳至主要内容
临床试验/CTRI/2022/10/046205
CTRI/2022/10/046205尚未招募不适用

Comparison of dynamic vault changes following implantation of two different models of phakic intraocular lenses.

Nethradhama superspeciality eye hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
changes seen in the phakic introcular lens vault in different light conditions is the primary outcome.

研究概览

简要总结

Eyecryl phakic or Eyecryl phakic toric IOL and Visian implantable collamer lens are posterior chamber phakic intraocular lens (pIOL) that have been reported to be safe and effective surgical option for correction of moderate to high myopia , hyperopia and astigmatism. Vault is the distance between anterior surface of crystalline lens and posterior surface of phakic iol. Low vault may lead to mechanical contact with the crystalline lens , which is responsible for high incidence of anterior capsular opacification and cataract formation. Conversely , excessively high vault causes mechanical contact between the pIOL and iris, resulting in inflammation , high intraocular pressure, angle closure glaucoma and pigment dispersion syndrome. As both models of pIOL are made up of different material , it will be interesting to evaluate the vault height in both brands in varying light conditions. In this is a prospective comparative  study we aim to compare the difference in dynamic vault between two lenses owing to difference in their material.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Myopia between -0.5 and -21 DS 2.Astigmatism between 0 to 6 DC.

排除标准

  • Anterior chamber depth less than 2.8mm
  • Endothelial cell density less than 1500 cells/mm3
  • Cataract chanes in crystalline lens.

结局指标

主要结局

changes seen in the phakic introcular lens vault in different light conditions is the primary outcome.

时间窗: vault is to be measured post surgery first day, 2 weeks and three months

次要结局

  • Adverse event at any follow up(2 weeks and 3 months)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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