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CompletedNCT03421769Updated Feb 28, 2020

Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns

An interventional study of EA and AMLK and LA and AMLK in Ocular Burns, sponsored by Yingfeng Zheng. Completed at 1 site in China. Open to participants aged 4 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Yingfeng Zheng · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
4 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ocular Burns

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03

Who can participate

Ages eligible
4 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureEA 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).

  • ProcedureLA 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.

05

What researchers measure

Primary outcomes

  1. Success rate of corneal reepithelialization in disease eyes.

    The percentage of patients with completely epithelized and avascular corneal surface in disease eyes.

    Time frame: 12 months

06

Study locations

1 site
  • Zhognshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
07

Registry details

Key details

Study ID
NCT03421769
Lead sponsor
Yingfeng Zheng
Responsible party
Yingfeng Zheng (Principal Investigator, Sun Yat-sen University) — Sponsor-investigator
First posted
Feb 5, 2018
Start date
Feb 9, 2018
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Feb 28, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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