Modified Corneal EA With Middle LKP for Severe Corneal Burn (NCT03498846) | Clinical Trial Compass
UnknownNot Applicable
Modified Corneal EA With Middle LKP for Severe Corneal Burn
China20 participantsStarted 2018-05-10
Plain-language 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.
Who can participate
Age range
4 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success rate of corneal reepithelialization in disease eyes