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

Sun Yat-sen University

Status: Unknown

Conditions: Corneal Transplantation

Treatments: Procedure: Limbal transplantation combined with central penetrating keratoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04490902

2020KYPJ111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Single graft corneal transplantation

Active Comparator group

Description:

Limbal transplantation combined with central penetrating keratoplasty from single donors.

Treatment:

Procedure: Limbal transplantation combined with central penetrating keratoplasty

Procedure: Limbal transplantation combined with central penetrating keratoplasty

Dual graft corneal transplantation

Experimental group

Description:

Limbal transplantation combined with central penetrating keratoplasty from different donors.

Treatment:

Procedure: Limbal transplantation combined with central penetrating keratoplasty

Procedure: Limbal transplantation combined with central penetrating keratoplasty