跳至主要内容
临床试验/CTRI/2018/09/015651
CTRI/2018/09/015651尚未招募Unknown

A Study on Efficacy and Visual outcome of Posterior chamber Phakic Intra-ocular lens in High Myopia

DR SIVAVIGANESH1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年9月17日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1. Improvement in Best corrected visual acuity

研究概览

简要总结

Phakic IOL means that natural crystalline lens is retained and an intraocular lens (IOL) is placed into the eye. The phakic IOL implant functions as an internal contact lens and the view through the phakic IOL is natural and of a good quality. Phakic IOLs are used to treat high myopia or hyperopia with or without astigmatism who are not fit for LASIK or mild keratoconus

Primary Objective of this study is Evaluate the Visual Outcome and Ensure the Safety of Posterior Chamber Refractive Implantable Lens (RIL) in High Myopic Patients

In this Study all Patients will be Thoroughly Evaluated Pre-Operatively and Follow Up done  at 1st week, 2nd Week, 4th Week , 3rd Month and 6th Month.The following Parameters will be assessed Visual Acuity, Anterior Chamber Depth, CCT, Endothelial Cell Count, IOP and Iridocorneal angle.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Age >21 years
  • Stable refraction
  • Patients with myopia >-6.00D
  • Iridocorneal angle > 30 degree
  • Anterior chamber depth >2.7mm
  • Endothelial cell count > 2500 cells/sq.mm
  • Central corneal thickness >0.400 mm.

排除标准

  • Age <18 years
  • Unstable refraction
  • Hyperopia
  • AC depth <2.7mm.
  • Iridocorneal angle <30 degrees
  • Endothelial cell count <2500 cells /sq mm
  • Central corneal thickness <0.400 mm.
  • Any Lens Changes 9.Any Retinal degeneration which cause Impaired vision 10.Any Inflammatory Pathologies of Eye 11.Any Previous Ocular Surgeries.

结局指标

主要结局

1. Improvement in Best corrected visual acuity

时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month

2.Anterior chamber depth

时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month

3.Iridocorneal angle

时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month

4.Endothelial count

时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month

6.Central corneal thickness

时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month

次要结局

  • 1.Intra Ocular Pressure(2.RIL Vaulting between Natural Lens and Phakic IOL)

研究者

发起方
DR SIVAVIGANESH
申办方类型
Other []

研究点 (1)

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