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临床试验/NCT00370812
NCT00370812Unknown2 期

The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2006年7月最近更新:
适应症

试验速览

阶段
2 期
入组人数
90
试验地点
2
主要终点
Epithelial defect healing

研究概览

简要总结

This is a randomized clinical trial study to identify the role of AMT (amniotic membrane transplantation) in treating epithelial defect, symblepharon prevention preventing corneal vascularization and opacity decreasing pain and improving visual acuity, and patients with acute chemical burns.

详细描述

The study is on patients with grade II-IV acute ocular chemical burns (Roper - Hall classification) in the first 2 weeks of injury.

After topical anesthesia, all patients initially will receive first aid therapy; which included irrigation with normal saline to normalize ocular surface PH and removal of early particulate maeuil and debris. After complete examination and obtaining informed consent, the patients will be randomized using a treatment assignment list to either AMT with conventional medical therapy (group A) or medical treatment only (group B). In the patients with bilateral injuries the eyes will be randomized separately. AMT will be performed within 24h of presentation. amniotic membrane will remain in place for 7-14 days. The patients will be examined at days 1, 3, 7, 10, 14, 21, 28 and then biweekly until 3 months and monthly until (1 year in every visit, visual acuity (by sneillen charts), reduction of pain (subjectively) size of corneal epithelial defect (by fluorseein satiny extent of corneal vascularization and opacity, and symblepharon formation will be assessed. Digital photographs at each visit will be obtained.

研究设计

研究类型
Interventional
分配方式
Randomized
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 chemical eye burn grade 2-4
  • Burning has been occurred in 2 weeks

排除标准

  • Grade I burnings
  • More than 2 weeks have passed of burning
  • Follow up of the patients has been disconnected in 6 month

结局指标

主要结局

Epithelial defect healing

时间窗: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year

Pain

时间窗: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year

Symblepharon formation

时间窗: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year

Visual acuity

时间窗: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year

Corneal opacity and vascularization

时间窗: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year

次要结局

未报告次要终点

研究者

研究点 (2)

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