Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns

Inclusion criteria

• Unilateral severe ocular burns 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.

Exclusion criteria

• 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 m2.
• 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 anti-glaucoma surgeries.