Corneal Epithelial Allograft From Living-related Donor for LSCD

Limbal Stem Cell Deficiency Clinical Trial

Official title:

A Non-randomized Controlled Clinical Trial of Epithelial Allograft Transplantation From Living-related Donors for the Treatment of Limbal Stem Cell Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217435
• Other study ID #: 2017KYPJ057
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: November 13, 2019

Study information

• Verified date: February 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency

Intervention

Procedure:
• Corneal epithelial allograft
A living-related donor's epithelial flap, equal in area to the recipient's diseased cornea bed, will be created using femtosecond laser technology. This corneal epithelial allograft is then ready for transplantation on the recipient's disease eye, following removal of the recipient's scarred and diseased epithelium.
• Limbal conjunctival allograft
A 3- to 5- clock hour limbal-conjunctival allograft will be obtained from the living-related eye. This is then ready for transplantation on the recipient's disease eye following removal of the recipient's scarred and diseased epithelium.

Device:
• Femtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation
• Diamond knife
A diamond knife to create a particular shaped limbal graft for transplantation

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chunxiao Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of corneal surface in the recipient	Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient	1 year
Primary	Restoration of corneal surface in the donor	Restoration of a completely epithelized, stable, and avascular corneal surface in the donor	1 year
Secondary	Uncorrected and best-corrected visual acuity of recipients and donors	To assess changes of uncorrected and best-corrected visual acuity using ETDRS chart.	1 year
Secondary	Corneal power, astigmatism and aberration of recipients and donors	To measure changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.	1 year
Secondary	Corneal sensation of recipients and donors	To measure corneal sensation using Cochet-Bonnet esthesiometer.	1 year
Secondary	Corneal thickness of recipients and donors	To measure corneal thickness using Anterior Segment Optical Coherence Tomograph (AS-OCT).	1 year
Secondary	Density of stromal nerve and stromal keratocytes of recipients and donors	To measure density of stromal nerve and stromal keratocytes using in vivo confocal microscopy	1 year
Secondary	Reconstruction of limbal palisades of Vogt of recipients	To assess reconstruction of limbal palisades of Vogt using in vivo confocal microscopy.	1 year
Secondary	Corneal graft rejection of recipients	To assess corneal graft rejection using slit-lamp microscopy.	1 year
Secondary	Corneal haze of recipients and donors	To assessing corneal haze using in vivo confocal microscopy	1 year