Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty

Corneal Transplantation Clinical Trial

Official title:

Suppression of Graft Rejection Using Mixed Component Cornea in the High-risk Keratoplasty，A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490902
• Other study ID #: 2020KYPJ111
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: July 2023

Study information

• Verified date: February 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Ting Huang, MD, PHD
• Phone: 86-13552338050
• Email: qingerdong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 donor's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Transplantation

Intervention

Procedure:
• Limbal transplantation combined with central penetrating keratoplasty
Limbal transplantation combined with central penetrating keratoplasty with single donor cornea
• Limbal transplantation combined with central penetrating keratoplasty
Limbal transplantation combined with central penetrating keratoplasty with mixed component cornea

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraocular pressure	Intraocular pressure will be measured by non contact tonometer as safety index	Before surgery, 1 week, 1 month, 3 months, 6 months, 12 months
Primary	The rate of corneal graft rejection at 12 months	The rejection index of corneal transplantation will be observed by slit lamp after surgery	12 months
Secondary	The changes of best corrected visual acuity	Best corrected visual acuity in different point will be compared with preoperative	Before surgery, 1 week, 1 month, 3 months, 6 months, 12 months
Secondary	The changes of corneal thickness depth	Corneal thickness depth will be measured by anterior segmental OCT and compared with preoperative	baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Secondary	Reconstruction of corneal limbal	Confocal microscopy will be used to define whether the structure of corneal limbal has reconstructed	baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Secondary	Endothelial Cell Density	Endothelial Cell Density will be measured by specular microscope to evaluate the loss of endothelial cells	baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Secondary	The rate of presence of goblet cells containing conjunctival epithelium on the corneal surface by impression cytology	Detects whether conjunctival epithelial and goblet cells have invaded the corneal surface by impression cytology, to observe the reconstruction of limbal function	baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months