Modified Corneal EA With Middle LKP for Severe Corneal Burn

• ClinicalTrials.gov Identifier: NCT03498846
• Recruitment Status: Unknown
• First Posted: April 17, 2018
• Last Update Posted: September 9, 2019
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Yingfeng Zheng, Sun Yat-sen University

Study Description

Brief Summary:

The purpose of this pilot study is to explore whether modified 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 corneal burn.

Condition or disease	Intervention/treatment	Phase
Corneal Burn	Procedure: Modified EA and AMLK; Procedure: LA and AMLK	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Modified Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Corneal Burn
• Actual Study Start Date: May 10, 2018
• Estimated Primary Completion Date: December 9, 2019
• Estimated Study Completion Date: May 9, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Modified EA and AMLK; Modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe corneal burn.	Procedure: Modified EA and AMLK; Two pieces of corneal epithelial tissue with 2mmx3mm 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 corneal burn.	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.

Outcome Measures

Primary Outcome Measures :

1. Success rate of corneal reepithelialization in disease eyes [ Time Frame: 12 months ]
   The success rate of patients with completely epithelized and avascular corneal surface in disease eyes

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Unilateral severe corneal burn 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.

Contacts and Locations

Contacts

Contact: Yingfeng Zheng; +8613922286455; zhyfeng@mail.sysu.edu.cn

Locations

China, Guangdong

Zhognshan Ophthalmic Center, Sun Yat-sen University; Recruiting

Guangzhou, Guangdong, China, 510000

Contact: Yizhi Liu

Sponsors and Collaborators

Sun Yat-sen University

More Information

• Responsible Party: Yingfeng Zheng, Clinical investigator, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03498846
• Other Study ID Numbers: 2018KYPJ070
• First Posted: April 17, 2018
• Last Update Posted: September 9, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Eye Burns; Burns; Wounds and Injuries; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases