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Modified Corneal EA With Middle LKP for Severe Corneal Burn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03498846
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : September 9, 2019
Information provided by (Responsible Party):
Yingfeng Zheng, Sun Yat-sen University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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.

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

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03498846

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Contact: Yingfeng Zheng +8613922286455

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China, Guangdong
Zhognshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yizhi Liu         
Sponsors and Collaborators
Sun Yat-sen University

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eye Burns
Wounds and Injuries
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases