A Clinical Trial of Corneal Epithelial Autograft Combined With Allogeneic Middle Lamellar Keratoplasty for Patients With Severe Ocular Burns

Yingfeng Zheng1 site in 1 country30 target enrollmentFebruary 9, 2018

ConditionsOcular Burns

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ocular Burns
Sponsor: Yingfeng Zheng
Enrollment: 30
Locations: 1
Primary Endpoint: Success rate of corneal reepithelialization in disease eyes.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this pilot study is to explore whether corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal autograft (LA) with AMLK for ocular surface reconstruction in patients with severe ocular burns.

Registry

clinicaltrials.gov

Start Date

February 9, 2018

End Date

December 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yingfeng Zheng

Responsible Party

Sponsor Investigator

Principal Investigator

Yingfeng Zheng

Principal Investigator

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Unilateral severe ocular burns with more than half limbal stem cells deficiency (LSCD). The history of the disease is at least 12 months at the time of screening visit.
•Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea.
•Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study.

Exclusion Criteria

•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 burns.
•Eyelids malposition.
•The center corneal thickness\<450µm, the depth of corneal opacity\<150µm or the full corneal lamellar opacity.
•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 HgA1c greater than 8.5%.
•Renal failure with creatinine clearance ≤ 25mL/min per 1.73 m
•Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L.