Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04490902
Status:
UNKNOWN
Last Update Posted:
2022-02-24
First Post:
2020-07-22
Brief Title:
Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty
Sponsor:
Zhongshan Ophthalmic Center Sun Yat-sen University
Organization:
Zhongshan Ophthalmic Center Sun Yat-sen University
Study Overview
Official Title:
Suppression of Graft Rejection Using Mixed Component Cornea in the High-risk KeratoplastyA Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
This study will observe the graft survival of high-risk corneal transplantation using mixed component cornea from different donors
Detailed Description:
Ocular trauma or infection lead to corneal limbal stem cell deficiency and central corneal opacification which could only be treated by central penetrating keratoplasty and limbal transplantation but the rejection rate is very high In clinical we found that limbal transplantation combined with central penetrating keratoplasty from different donors can keep the graft transparent for a long time this result also be found in organ transplantation multiple donor organ transplantation could reduce rejection risk in liver and kidney transplantation Therefore it is speculated that there are different MHC antigens from different donors which cause different reactions after transplantation Because there are a large number of Langerhans cells abundant blood vessels and lymphatic in the limbal so the rejection occurs early and severely Continuous and intense limbal rejection leads to the depletion of recipient T cells lead to the immune tolerance of another donors central corneal tissue In this project central penetrating keratoplasty and limbal transplantation from different donors will be carried out and the graft survival of high-risk corneal transplantation will be observed in clinical to find a new method for high-risk corneal transplant patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None