跳至主要内容
临床试验/CTRI/2019/11/021841
CTRI/2019/11/021841尚未招募未知

A prospective clinical Study to evaluate the Safety and Efficacy of two different 0.1% Riboflavin used in Corneal Cross-linking treatment for patients with Keratoconus

BIOTECH HEALTHCARE PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Unilateral/bilateral
  • 2.A diagnosis of keratoconus.
  • 3.Progressing keratoconus.
  • 4.Patients with Keratometric readings <= 55 D
  • 5.Patients >= 18 years of age
  • 6.Patients with clear central cornea, without apical scarring.
  • 7.Patients with corneal thickness >= 400 microns at the thinnest point.
  • 8.Patient willing to participate and sign informed consent
  • 9.Patient willing to come for all post-operative follow-up procedures as defined in study protocol.

排除标准

  • 1.Eyes classified as either normal, atypical normal (except corneal ectasia), or keratoconus suspect on the severity grading scheme.
  • 2.A history of previous corneal surgery or the insertion of intrastromal ring implantation in the eye(s) to be treated.
  • 3.Previous corneal or Intraocular surgery
  • 4.Pellucid marginal corneal degeneration
  • 5.Eyes which are aphakic or pseudophakic and do not have a UV blocking lens implanted.
  • 6.A history of delayed epithelial healing.
  • 7.Patients with nystagmus or any other condition that would have prevented a steady gaze during the CXL treatment or other diagnostic tests.
  • 8.Pregnancy & Lactation
  • 9.Concurrent participation in another drug or device Study.

研究者

发起方
BIOTECH HEALTHCARE PVT LTD

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