Corneal Epithelial Autograft for LSCD

NCT ID: NCT03217487

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2019-12-30

Brief Summary

The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction in patients with limbal stem cell deficiency (LSCD).

Conditions

Limbal Stem Cell Deficiency

Study Design

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

Study Groups

Corneal epithelial autograft

Femtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD

Group Type: EXPERIMENTAL

Corneal epithelial autograft

Intervention Type: PROCEDURE

Epithelial tissue, equal in area to the diseased eye's cornea bed, will be obtained from the fellow eye using femtosecond laser technology. This corneal epithelial autograft is then ready for transplantation on the disease eye, following removal of scarred and diseased epithelium.

Femtosecond laser

Intervention Type: DEVICE

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

Limbal conjunctival autograft

Diamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD

Group Type: ACTIVE_COMPARATOR

Limbal conjunctival autograft

Intervention Type: PROCEDURE

A 3- to 5- clock hour limbal-conjunctival autograft will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following removal of scarred and diseased epithelium.

Diamond knife

Intervention Type: DEVICE

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

Interventions

Corneal epithelial autograft

Epithelial tissue, equal in area to the diseased eye's cornea bed, will be obtained from the fellow eye using femtosecond laser technology. This corneal epithelial autograft is then ready for transplantation on the disease eye, following removal of scarred and diseased epithelium.

Intervention Type: PROCEDURE

Limbal conjunctival autograft

A 3- to 5- clock hour limbal-conjunctival autograft will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following removal of 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. Unilateral 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. 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

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 pterygium;

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.

• 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

Guanzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingfeng Zheng, M.D.Ph.D.

Role: CONTACT

yingfeng.zheng@qq.com

+8613922286455

Facility Contacts

Yingfeng Zheng, M.D. Ph.D.

Role: primary

Other Identifiers

2017KYPJ051

Identifier Type: -

Identifier Source: org_study_id