Corneal Epithelial Allograft From Living-related Donor for LSCD

Not Applicable

Completed

• Conditions: Limbal Stem Cell Deficiency
• Interventions: Procedure: Limbal conjunctival allograft; Procedure: Corneal epithelial allograft; Device: Femtosecond laser; Device: Diamond knife

• Registration Number: NCT03217435
• Lead Sponsor: Chunxiao Wang

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-07-27
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limbal conjunctival allograft	Limbal conjunctival allograft	Diamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)
Cornea epithelial allograft	Corneal epithelial allograft	Femtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)
Cornea epithelial allograft	Femtosecond laser	Femtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)
Limbal conjunctival allograft	Diamond knife	Diamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)

Primary Outcome Measures

Name	Time	Method
Restoration of corneal surface in the donor	1 year	Restoration of a completely epithelized, stable, and avascular corneal surface in the donor
Restoration of corneal surface in the recipient	1 year	Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient

Secondary Outcome Measures

Name	Time	Method
Corneal haze of recipients and donors	1 year	To assessing corneal haze using in vivo confocal microscopy
Uncorrected and best-corrected visual acuity of recipients and donors	1 year	To assess changes of uncorrected and best-corrected visual acuity using ETDRS chart.
Corneal power, astigmatism and aberration of recipients and donors	1 year	To measure changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
Corneal sensation of recipients and donors	1 year	To measure corneal sensation using Cochet-Bonnet esthesiometer.
Density of stromal nerve and stromal keratocytes of recipients and donors	1 year	To measure density of stromal nerve and stromal keratocytes using in vivo confocal microscopy
Reconstruction of limbal palisades of Vogt of recipients	1 year	To assess reconstruction of limbal palisades of Vogt using in vivo confocal microscopy.
Corneal graft rejection of recipients	1 year	To assess corneal graft rejection using slit-lamp microscopy.
Corneal thickness of recipients and donors	1 year	To measure corneal thickness using Anterior Segment Optical Coherence Tomograph (AS-OCT).

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity; 🇨🇳 Guangzhou, Guangdong, China