Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty (NCT04490902) | Clinical Trial Compass
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Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty
China80 participantsStarted 2020-08-18
Plain-language summary
Because of the immunologically privileged nature of the cornea, the graft rejection rate is less than 10% for low-risk keratoplasty. But when the cornea performed 2 or more quadrants of corneal neovascularization after ocular trauma or infection, the graft rejection rate is more than 65%, it is called high-risk keratoplasty.
This study will observe the graft survival of high-risk corneal transplantation using mixed component cornea from different donors.
Who can participate
Age range
18 Years – 70 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:
* Central corneal opacity involving full layer
* Corneal neovascularization in two or more quadrants
* Patients must be willing and able to return for scheduled follow-up examinations for 12 months after surgery
* Ages：18 -70 Years
Exclusion Criteria:
* Central corneal opacity not involving the endothelial layer
* Less than two quadrants of corneal neovascularization
* History of Stevens-Johnson syndrome or Sjogren's syndrome
* Severe eyelid and conjunctival scar
* Loss of vision in contralateral eye
* Pregnant and lactating women
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
The rate of corneal graft rejection at 12 months
Timeframe: 12 months
Trial details
NCT IDNCT04490902
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University