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临床试验/NCT06070883
NCT06070883已完成不适用

Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Corneal Pain

研究概览

简要总结

Corneal infection or infectious keratitis (IK) is the most common cause of corneal blindness worldwide, particu-larly in the developing countries1. The incidence was estimated at 2.5-799 per 100,000 population/year. It is a painful and potentially blinding ocular emergency that often requires hospital admission for intensive medical and/or surgical treatment. Depending on the geographical and temporal variations and population-based risk factors (e.g. agricultural practice, trauma, use of contact lens and others), bacteria and fungi have been shown to be the main causative microorganisms for IK, followed by viruses, parasites and polymicrobial infection. Amniotic membrane (AM) is the innermost layer of the placenta, which consists of a single layer of meta-bolically active epithelium, a thick basement membrane, and an avascular stromal matrix (15).

It has been shown to exhibit a wide array of biological properties, including wound healing, anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others. To date, a number of studies have evaluated the benefit of AMT for treating active IK, though the majority of them were of small case series or case reports. In clinical practice, AMT is usually reserved as a second-line therapy in IK, mainly to promote cornea healing in non-healing ulcer after the sterilization phase.

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

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Size more than 5 mm.
  • Deep ulcers i.e. > 50% stromal thickness.
  • Located within 3mm of the visual axis.
  • Patients with descemetoceles and corneal perforations will also be included

排除标准

  • Corneal ulcers of size < 5mm depth < 50%
  • Associated glaucoma
  • Associated chronic dacryocystitis
  • Ulcers with entropion

结局指标

主要结局

Corneal Pain

时间窗: three months post operative

it will be meaured by the Visual analouge scale

Size of the ulcer

时间窗: three months post operative

it will be meaured in mellimeter

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

Ehab Tharwat

Principal investigator

Al-Azhar University

研究点 (2)

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