Corneal Epithelial Allograft From Living-related Donor for LSCD

NCT ID: NCT03217435

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2019-11-13

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).

Conditions

Limbal Stem Cell Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cornea epithelial allograft

Femtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)

Group Type: EXPERIMENTAL

Corneal epithelial allograft

Intervention Type: PROCEDURE

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.

Femtosecond laser

Intervention Type: DEVICE

A commercial femtosecond laser to create a particular shaped graft for transplantation

Limbal conjunctival allograft

Diamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)

Group Type: ACTIVE_COMPARATOR

Limbal conjunctival allograft

Intervention Type: PROCEDURE

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.

Diamond knife

Intervention Type: DEVICE

A diamond knife to create a particular shaped limbal graft for transplantation

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Femtosecond laser

A commercial femtosecond laser to create a particular shaped graft for transplantation

Intervention Type: DEVICE

Diamond knife

A diamond knife to create a particular shaped limbal graft for transplantation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chunxiao Wang

OTHER

Sponsor Role: lead

Responsible Party

Chunxiao Wang

Clinical investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yizhi Liu, M.D.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Ting Huang, M.D.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2017KYPJ057

Identifier Type: -

Identifier Source: org_study_id