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临床试验/NCT03801590
NCT03801590Unknown不适用

Safety and Efficacy Of Corneal Collagen Crosslinking (CXL) In Infectious Keratitis

Assiut University0 个研究点目标入组 20 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Determine the duration for corneal ulcer healing

研究概览

简要总结

Microbial keratitis is an infection of the cornea that is associated with risk of permanent visual impairment.

It can be caused by bacteria, virus, fungus, protozoa and parasites. The common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensation impairment, chronic use of topical steroids and systemic immunosuppression .

详细描述

The spectrum of bacterial keratitis can also be influenced by geographic and climatic factors.

The treatment usually consist of Topical administered antibiotics .the emergence of multidrug-resistant bacteria is a concern that might complicate the treatment and cure of infectious keratitis.

Collagen cross linking (CXL) using ultraviolet-A (UV-A) and riboflavin in a treatment that was developed to increase the biochemical strength of the cornea The procedure is based on using riboflavin as a photosensitizer, which generates reactive oxygen species when activated by UV-A at 365 or370 nm.

The standard technique (epi-off) also called Dresden Protocol includes removal of the epithelium in order to expose the underlying stroma to riboflavin, which is otherwise incompletely absorbed by the epithelium because of tight junctions. The area of corneal epithelium removed has a diameter of 6.0 to 8.5 mm. A crosslinking procedure without epithelial removal could also be performed (epi-on). It would likely be less painful compared to the standard procedure.

The crosslinking process generates reactive oxygen species that can damage the cell walls of pathogens. CXL induces formation of new covalent bonds thereby rendering the corneal stroma biomechanically stronger and more resistant to enzymatic digestion . This can potentially limit the spread of infection. Furthermore, CXL-induced apoptosis could contribute to the reduction of inflammatory response during corneal infection .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with proved bacterial, fungal, acanthamoeba microbial keratitis .
  • Patient willing to comply with all study procedures .

排除标准

  • Severe corneal scarring or opacification .
  • Patients with viral infectious keratitis
  • Prior herpetic infections .
  • Patients with any coexisting ocular pathology,ocular surface disease .
  • Patients with Autoimmune disease.
  • Pregnant women .
  • Corneal Thickness of less than 400 microns .

结局指标

主要结局

Determine the duration for corneal ulcer healing

时间窗: one year

By follow up with photography before crosslinking and one week after performing cxl.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Asem

principal investigator

Assiut University

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