Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT03217435
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\<450µm, the depth of corneal opacity \> 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 \< 150,000 or \> 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\<450µm, the depth of corneal opacity \> 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 \< 150,000 or \> 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
80 Years
Study:
NCT03217435
Study Brief:
Protocol Section:
NCT03217435