Corneal Epithelial Autograft for LSCD

Limbal Stem Cell Deficiency Clinical Trial

Official title:

A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for the Treatment of Limbal Stem Cell Deficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217487
• Other study ID #: 2017KYPJ051
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng, M.D.Ph.D.
• Phone: +8613922286455
• Email: yingfeng.zheng[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency

Intervention

Procedure:
• 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.
• 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.

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	Guanzhou	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 diseased eye	Restoration of a completely epithelized, stable, and avascular corneal surface in the diseased eye.	1 year
Primary	Restoration of corneal surface in the fellow eye	Restoration of a completely epithelized, stable, and avascular corneal surface in the fellow eye.	1 year
Secondary	Uncorrected and best-corrected visual acuity in both eyes	To measure changes of uncorrected and best-corrected visual acuity using ETDRS chart.	1 year
Secondary	Corneal power, astigmatism and aberration in both eyes	To changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.	1 year
Secondary	Corneal sensation in both eyes	To assess corneal sensation using Cochet-Bonnet esthesiometer.	1 year
Secondary	Corneal thickness in both eyes	To measure corneal thickness using anterior segment optical coherence tomography (AS-OCT).	1 year
Secondary	Density of stromal nerve and stromal keratocytes in both eyes	To assessing density of stromal nerve and stromal keratocytes using in vivo confocal microscopy.	1 year
Secondary	Reconstruction of limbal palisades of Vogt in the diseased eye	To assessing reconstruction of limbal palisades of Vogt using in vivo confocal microscopy.	1 year
Secondary	Corneal haze in both eyes	To measuring corneal haze using in vivo confocal microscopy.	1 year