Ocular BurnsNCT03421769
Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns
A study testing EA and AMLK and LA and AMLK in people with Ocular Burns, run by Yingfeng Zheng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Ocular Burns
- What is being tested?
- EA and AMLK and LA and AMLK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: 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.
- Conditions
- Ocular Burns
- Being tested
- EA and AMLK, LA and AMLK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA and AMLKProcedure or surgery
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).
LA and AMLKProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EA and AMLK | Experimental | Corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe ocular burns. Receives: Procedure: EA and AMLK |
| LA and AMLK | Active comparator | Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe ocular burns. Receives: Procedure: LA and AMLK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of corneal reepithelialization in disease eyes.
The percentage of patients with completely epithelized and avascular corneal surface in disease eyes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start9 Feb 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yingfeng Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingfeng Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421769
- Sponsor's protocol ID
- 2018KYPJ003
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Corneal Epithelial Autograft Combined With Allogeneic Middle Lamellar Keratoplasty for Patients With Severe Ocular Burns
- ClinicalTrials.gov ID
- NCT03421769
- Acronym / sponsor ID
- 2018KYPJ003
- Conditions
- Ocular Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yingfeng ZhengUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA and AMLK | Experimental | Procedure: EA and AMLKCorneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe ocular burns. |
| LA and AMLK | Active comparator | Procedure: LA and AMLKLimbal autograft (LA) combined with AMLK is used for the treatment of patients with severe ocular burns. |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EA and AMLKA 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). | Procedure or surgery | EA and AMLK |
| LA and AMLKA 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. | Procedure or surgery | LA and AMLK |
Primary outcome
Success rate of corneal reepithelialization in disease eyes.
Time frame: 12 months
The percentage of patients with completely epithelized and avascular corneal surface in disease eyes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Related trials for Ocular Burns
RecruitingObservational study
OCTA Evaluated the Efficacy of Glucocorticoid Retrobulbar Injection in Retinal Photo-injury
Retinal Light Damage, Photic Retinopathy
Recruiting
Vit-A-Vision® Clinical Investigation
Burning Eye, Irritation; Eyeball
Not yet recruitingPhase 2
Treatment of Severe Ocular Chemical Burns by Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells: An Open-Label, Single-Arm, Multicenter Phase II Trial
Chemical Burns, Ocular Burns
Recruiting
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Macular Degeneration, Senile, Laser Burn of Retina
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EA and AMLK and LA and AMLK in people with Ocular Burns, run by Yingfeng Zheng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of corneal reepithelialization in disease eyes. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.