Corneal Epithelial Allograft From Living-related Donor for LSCD

Inclusion criteria

• 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.

Exclusion criteria

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.

Donors:

• 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.