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
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