corneal epithelial allograft from living-related donor for lscd

Conditions: Limbal Stem Cell Deficiency

Summary: 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).


Eligibility criteria:
inclusion criteria: 1. lscd secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit; 2. presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea; 3. having a human leukocyte antigen (hla)-matched living-related donor (≥4/6 hla-a/b/dr matched); 4. 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: 1. lscd of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement; 2. lscd by ocular surface disorders other than ocular burn; 3. eyelids malposition; 4. the center corneal thickness\ 150µm; 5. high myopia with a spherical equivalent of -15.0 d or less; 6. corneal or ocular surface infection within 30 days prior to study entry; 7. ocular surface malignancy; 8. uncontrolled diabetes with most recent hemoglobin a1c greater than 8.5%; 9. renal failure with creatinine clearance\< 25ml/min; 10. alanine aminotransferase \> 40iu/l, or aspartate aminotransferase \> 40iu/l; 11. platelet levels \ 450,000 per microliter; 12. hemoglobin \< 12.0 g/dl (male) or \< 11.0 g/dl (female); 13. 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; 14. pregnancy (positive test) or lactation; 15. participation in another simultaneous medical investigation or clinical trial; 16. severe cicatricial eye disease; conjunctival scarring with fornix shortening; 17. ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases; 18. severe dry eye disease as determined by schirmer's test \< 2mm at least in one eye; 19. 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; 20. signs of current infection, including fever and treatment with antibiotics; 21. active immunological diseases; 22. history of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries. donors: 1. cornea diseases (epithelial defects, neovascularization, etc.); 2. eyelids malposition; 3. the center corneal thickness\ 150µm; 4. high myopia with a spherical equivalent of -15.0 d or less; 5. corneal or ocular surface infection within 30 days prior to study entry; 6. ocular surface malignancy; 7. uncontrolled diabetes with most recent hemoglobin a1c greater than 8.5%; 8. renal failure with creatinine clearance\< 25ml/min; 9. alanine aminotransferase \> 40iu/l, or aspartate aminotransferase \> 40iu/l; 10. platelet levels \ 450,000 per microliter; 11. hemoglobin \< 12.0 g/dl (male) or \< 11.0 g/dl (female); 12. 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; 13. pregnancy (positive test) or lactation; 14. participation in another simultaneous medical investigation or clinical trial; 15. severe cicatricial eye disease; conjunctival scarring with fornix shortening; 16. ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases; 17. severe dry eye disease as determined by schirmer's test \< 2mm at least in one eye; 18. 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; 19. signs of current infection, including fever and treatment with antibiotics; 20. active immunological diseases; 21. history of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.