跳至主要内容
临床试验/CTRI/2024/12/077712
CTRI/2024/12/077712尚未招募不适用

Scleral fixation of Posterior chamber Intraocular lens- Flange Yamane technique vs Glued Intrascleral Haptic fixation technique: a case control study

All India Institute of medical sciences New Delhi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To assess and compare the clinical outcomes and IOL stability between flange Yamane technique and Glued Intrascleral haptic fixated intraocular lens.

研究概览

简要总结

The primary goal of this case control study is to critically evaluate and compare the two revolutionary scleral fixation of intraocular lens approaches - Flanged Yamane technique and Glued intrascleral haptic fixation technique in terms of visual outcomes, intraocular pressure, IOL stability  and postoperative complications where 40 aphakic patients coming to RP centre AIIMS Delhi -of age within 18 to 60 years with inadequate capsular support ,no underlying ocular pathology are included and evaluated.  20 patients will be taken as case and 20 as controls and undergo Flanged Yamane technique and Glued intrascleral haptic fixation technique respectively and will be followed up after 1 month, 3 month and 6 month and evaluated and analysed to find out which technique is superior over other in terms of clinical outcomes and complications.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Aphakia inadequate capsular support
  • Age 18 to 60 years
  • Specular count greater than 1500 cells/mm2
  • Eyes without underlying ocular pathology.

排除标准

  • Age less than 17 yrs and greater than 60 yrs
  • Eyes with underlying ocular pathology, namely keratopathy, glaucoma, retinopathy
  • Eyes with a specular count of less than 1500 /mm2
  • Patients not willing for follow up.

结局指标

主要结局

To assess and compare the clinical outcomes and IOL stability between flange Yamane technique and Glued Intrascleral haptic fixated intraocular lens.

时间窗: 1 month, 3 month and 6 month

次要结局

  • to compare intraoperative iop, and postoperative complications between flange Yamane technique and Glued Intrascleral haptic fixated intraocular lens.(1 month, 3 month and 6 month)

研究者

发起方
All India Institute of medical sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Gnanambiga

All India institute of medical sciences New Delhi

研究点 (1)

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