Corneal BurnNCT03498846
Modified Corneal EA With Middle LKP for Severe Corneal Burn
A study testing Modified EA and AMLK and LA and AMLK in people with Corneal Burn, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Corneal Burn
- What is being tested?
- Modified 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2018to 9 May 2020
- 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 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.
- 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 20Show 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yizhi Liu
About this study
Official title: Modified Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Corneal Burn
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.
- Conditions
- Corneal Burn
- Being tested
- Modified EA and AMLK, LA and AMLK
- Medical subject headings
- Eye Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified EA and AMLKProcedure or surgery
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).
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 |
|---|---|---|
| Modified EA and AMLK | Experimental | Modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe corneal burn. Receives: Procedure: Modified EA and AMLK |
| LA and AMLK | Active comparator | Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe corneal burn. 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 success rate 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 posted17 Apr 2018
- Study start10 May 2018
- Primary completion9 Dec 2019 (estimated)
- Study completion9 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal BurnStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498846
- Sponsor's protocol ID
- 2018KYPJ070
- Status last verified
- Sep 2019
- First submitted
- 7 Apr 2018
- Last updated
- 9 Sep 2019
- 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 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Corneal Burn
- ClinicalTrials.gov ID
- NCT03498846
- Acronym / sponsor ID
- 2018KYPJ070
- Conditions
- Corneal Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 9 Dec 2019 (estimated)
- Study completion
- 9 May 2020 (estimated)
- First posted
- 17 Apr 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified EA and AMLK | Experimental | Procedure: Modified EA and AMLKModified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe corneal burn. |
| LA and AMLK | Active comparator | Procedure: LA and AMLKLimbal autograft (LA) combined with AMLK is used for the treatment of patients with severe corneal burn. |
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 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.
- 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 (20 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 |
|---|---|---|
| Modified EA and AMLKTwo 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). | Procedure or surgery | Modified 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 success rate of patients with completely epithelized and avascular corneal surface in disease eyes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified EA and AMLK and LA and AMLK in people with Corneal Burn, run by Sun Yat-sen University 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 20 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingfeng Zheng (+8613922286455, zhyfeng@mail.sysu.edu.cn), or a site near the patient. 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 9 Sep 2019.