Back to resultsCorneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns
Primary Purpose
Ocular Burns
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EA and AMLK
LA and AMLK
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Burns
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 m2.
- Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L.
- Platelet levels < 150,000 or > 450,000 per microliter.
- Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
- 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.
- Pregnancy (positive test) or lactation.
- Participation in another simultaneous medical investigation or clinical trial.
- Severe cicatricial eye disease; Conjunctival scarring with fornix shortening.
- Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases.
- Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye.
- 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.
- Signs of current infection, including fever and treatment with antibiotics.
- Active immunological diseases.
- History of anti-glaucoma surgeries.
Sites / Locations
- Zhognshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EA and AMLK
LA and AMLK
Arm Description
Corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe ocular burns.
Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe ocular burns.
Outcomes
Primary Outcome Measures
Success rate of corneal reepithelialization in disease eyes.
The percentage of patients with completely epithelized and avascular corneal surface in disease eyes.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03421769
Brief Title
Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns
Official Title
A Clinical Trial of Corneal Epithelial Autograft Combined With Allogeneic Middle Lamellar Keratoplasty for Patients With Severe Ocular Burns
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yingfeng Zheng
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EA and AMLK
Arm Type
Experimental
Arm Description
Corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe ocular burns.
Arm Title
LA and AMLK
Arm Type
Active Comparator
Arm Description
Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe ocular burns.
Intervention Type
Procedure
Intervention Name(s)
EA and AMLK
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
LA and AMLK
Intervention Description
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 Measure Information:
Title
Success rate of corneal reepithelialization in disease eyes.
Description
The percentage of patients with completely epithelized and avascular corneal surface in disease eyes.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 m2.
Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L.
Platelet levels < 150,000 or > 450,000 per microliter.
Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
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.
Pregnancy (positive test) or lactation.
Participation in another simultaneous medical investigation or clinical trial.
Severe cicatricial eye disease; Conjunctival scarring with fornix shortening.
Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases.
Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye.
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.
Signs of current infection, including fever and treatment with antibiotics.
Active immunological diseases.
History of anti-glaucoma surgeries.
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
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Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns
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