Corneal Epithelial Autograft for LSCD

Not Applicable

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

• Registration Number: NCT03217487
• Lead Sponsor: Chunxiao Wang

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).

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: 2017-07-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corneal epithelial autograft	Femtosecond laser	Femtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD
Limbal conjunctival autograft	Limbal conjunctival autograft	Diamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD
Limbal conjunctival autograft	Diamond knife	Diamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD
Corneal epithelial autograft	Corneal epithelial autograft	Femtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD

Primary Outcome Measures

Name	Time	Method
Restoration of corneal surface in the diseased eye	1 year	Restoration of a completely epithelized, stable, and avascular corneal surface in the diseased eye.
Restoration of corneal surface in the fellow eye	1 year	Restoration of a completely epithelized, stable, and avascular corneal surface in the fellow eye.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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