NCT03217435已完成不适用
A Non-randomized Controlled Clinical Trial of Epithelial Allograft Transplantation From Living-related Donors for the Treatment of Limbal Stem Cell Deficiency
Chunxiao Wang1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Restoration of corneal surface in the donor
研究概览
简要总结
The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial allograft from living-related donor is more effective than limbal conjunctival allograft from living-related donor for ocular surface reconstruction in patients with limbal stem cell deficiency (LSCD).
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LSCD secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit;
- •Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea;
- •Having a human leukocyte antigen (HLA)-matched living-related donor (≥4/6 HLA-A/B/DR matched);
- •Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.
排除标准
- •Recipients:
- •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 burn;
- •Eyelids malposition;
- •The center corneal thickness<450µm, the depth of corneal opacity > 150µm;
- •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 Hemoglobin A1c greater than 8.5%;
- •Renal failure with creatinine clearance< 25ml/min;
- •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;
- •Active immunological diseases;
- •History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
- •Cornea diseases (epithelial defects, neovascularization, etc.);
- •Eyelids malposition;
- •The center corneal thickness<450µm, the depth of corneal opacity > 150µm;
- •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 Hemoglobin A1c greater than 8.5%;
- •Renal failure with creatinine clearance< 25ml/min;
- •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;
- •Active immunological diseases;
- •History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
结局指标
主要结局
Restoration of corneal surface in the donor
时间窗: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the donor
Restoration of corneal surface in the recipient
时间窗: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient
次要结局
- Corneal haze of recipients and donors(1 year)
- Uncorrected and best-corrected visual acuity of recipients and donors(1 year)
- Corneal power, astigmatism and aberration of recipients and donors(1 year)
- Corneal sensation of recipients and donors(1 year)
- Density of stromal nerve and stromal keratocytes of recipients and donors(1 year)
- Reconstruction of limbal palisades of Vogt of recipients(1 year)
- Corneal graft rejection of recipients(1 year)
- Corneal thickness of recipients and donors(1 year)
研究者
Chunxiao Wang
Clinical investigator
Sun Yat-sen University
研究点 (1)
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