A Non-randomized Controlled Clinical Trial of Epithelial Allograft Transplantation From Living-related Donors for the Treatment of Limbal Stem Cell Deficiency

Chunxiao Wang1 site in 1 country20 target enrollmentJuly 27, 2017

ConditionsLimbal Stem Cell Deficiency

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Limbal Stem Cell Deficiency
Sponsor: Chunxiao Wang
Enrollment: 20
Locations: 1
Primary Endpoint: Restoration of corneal surface in the donor
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 27, 2017

End Date

November 13, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chunxiao Wang

Responsible Party

Sponsor Investigator

Principal Investigator

Chunxiao Wang

Clinical investigator

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•LSCD secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit;
•Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea;
•Having a human leukocyte antigen (HLA)-matched living-related donor (≥4/6 HLA-A/B/DR matched);
•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:
•LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement;
•LSCD by ocular surface disorders other than ocular burn;
•Eyelids malposition;
•The center corneal thickness\<450µm, the depth of corneal opacity \> 150µm;
•High myopia with a spherical equivalent of -15.0 D or less;
•Corneal or ocular surface infection within 30 days prior to study entry;
•Ocular surface malignancy;
•Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
•Renal failure with creatinine clearance\< 25ml/min;

Outcomes

Primary Outcomes

Restoration of corneal surface in the donor

Time Frame: 1 year

Restoration of a completely epithelized, stable, and avascular corneal surface in the donor

Restoration of corneal surface in the recipient

Time Frame: 1 year

Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient

Secondary Outcomes

Corneal haze of recipients and donors(1 year)
Uncorrected and best-corrected visual acuity of recipients and donors(1 year)
Corneal power, astigmatism and aberration of recipients and donors(1 year)
Corneal sensation of recipients and donors(1 year)
Density of stromal nerve and stromal keratocytes of recipients and donors(1 year)
Reconstruction of limbal palisades of Vogt of recipients(1 year)
Corneal graft rejection of recipients(1 year)
Corneal thickness of recipients and donors(1 year)