NCT03498846Unknown不适用
Modified Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Corneal Burn
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Success rate of corneal reepithelialization in disease eyes
研究概览
简要总结
The purpose of this pilot study is to explore whether modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal autograft (LA) with AMLK for ocular surface reconstruction in patients with severe corneal burn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral severe corneal burn with more than half limbal stem cells deficiency (LSCD). The history of the disease is at least 12 months at the time of screening visit.
- •Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea.
- •Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study.
排除标准
- •LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement.
- •LSCD by ocular surface disorders other than ocular burns.
- •Eyelids malposition.
- •The center corneal thickness<450µm, the depth of corneal opacity<150µm or the full corneal lamellar opacity.
- •High myopia with a spherical equivalent of -15.0 D or less.
- •Corneal or ocular surface infection within 30 days prior to study entry.
- •Ocular surface malignancy.
- •Uncontrolled diabetes with most recent HgA1c greater than 8.5%.
- •Renal failure with creatinine clearance ≤ 25mL/min per 1.73 m
- •Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L.
- •Platelet levels < 150,000 or > 450,000 per microliter.
- •Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
- •Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy.
- •Pregnancy (positive test) or lactation.
- •Participation in another simultaneous medical investigation or clinical trial.
- •Severe cicatricial eye disease; Conjunctival scarring with fornix shortening.
- •Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases.
- •Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye.
- •Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
- •Signs of current infection, including fever and treatment with antibiotics.
研究组 & 干预措施
Modified EA and AMLK
Experimental
Modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe corneal burn.
干预措施: Modified EA and AMLK (Procedure)
LA and AMLK
Active Comparator
Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe corneal burn.
干预措施: LA and AMLK (Procedure)
结局指标
主要结局
Success rate of corneal reepithelialization in disease eyes
时间窗: 12 months
The success rate of patients with completely epithelized and avascular corneal surface in disease eyes
次要结局
未报告次要终点
研究者
Yingfeng Zheng
Clinical investigator
Sun Yat-sen University
研究点 (1)
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