Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Burns
• Intervention / Treatment: Procedure: LA and AMLK; Procedure: EA and AMLK

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhognshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea.
3. 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:

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 ocular burns.
3. Eyelids malposition.
4. The center corneal thickness<450µm, the depth of corneal opacity<150µm or the full corneal lamellar opacity.
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 HgA1c greater than 8.5%.
9. Renal failure with creatinine clearance ≤ 25mL/min per 1.73 m2.
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 anti-glaucoma surgeries.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EA and AMLK; Corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe ocular burns.	Procedure: EA and AMLK; A 7-9mm diameter corneal epithelial tissue will be obtained from the fellow eye using femtosecond laser technology. This epithelial autograft (EA) is then ready for transplantation on the disease eye, following the procedure of allogeneic middle lamellar keratoplasty (AMLK).
Active Comparator: LA and AMLK; Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe ocular burns.	Procedure: LA and AMLK; A 3-clock-hour limbal autograft (LA) will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following the procedure of AMLK.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of corneal reepithelialization in disease eyes.	The percentage of patients with completely epithelized and avascular corneal surface in disease eyes.	12 months

Collaborators and Investigators

• Sponsor: Yingfeng Zheng

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: January 20, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 2018KYPJ003

Drug and device information, study documents

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