Corneal Epithelial Autograft for LSCD

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

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).

Study Overview

• Status: Unknown
• Conditions: Limbal Stem Cell Deficiency
• Intervention / Treatment: Device: Femtosecond laser; Device: Diamond knife; Procedure: Corneal epithelial autograft; Procedure: Limbal conjunctival autograft

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corneal epithelial autograft; Femtosecond laser assisted corneal epithelial autograft from the other eye in the treatment of LSCD	Device: Femtosecond laser; A commercial femtosecond laser to create a particular shaped graft for transplantation; 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.
Active Comparator: Limbal conjunctival autograft; Diamond knife assisted limbal conjunctival autograft from the other eye in the treatment of LSCD	Device: Diamond knife; A diamond knife to create a particular shaped limbal graft for transplantation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of corneal surface in the diseased eye	Restoration of a completely epithelized, stable, and avascular corneal surface in the diseased eye.	1 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected and best-corrected visual acuity in both eyes	To measure changes of uncorrected and best-corrected visual acuity using ETDRS chart.	1 year
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
Corneal sensation in both eyes	To assess corneal sensation using Cochet-Bonnet esthesiometer.	1 year
Corneal thickness in both eyes	To measure corneal thickness using anterior segment optical coherence tomography (AS-OCT).	1 year
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
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
Corneal haze in both eyes	To measuring corneal haze using in vivo confocal microscopy.	1 year

Collaborators and Investigators

• Sponsor: Chunxiao Wang

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017KYPJ051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No