NCT04490902

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

August 18, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

July 22, 2020

Last Update Submit

February 22, 2022

Conditions

Corneal Transplantation

Keywords

High-risk corneal transplantationPenetrating keratoplastyLimbal transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The changes of best corrected visual acuity

    Before surgery, 1 week, 1 month, 3 months, 6 months, 12 months

  • The changes of corneal thickness depth

    baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months

  • Reconstruction of corneal limbal

    baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months

  • Endothelial Cell Density

    baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months

  • The rate of presence of goblet cells containing conjunctival epithelium on the corneal surface by impression cytology

    baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months

Other Outcomes (1)

  • Intraocular pressure

    Before surgery, 1 week, 1 month, 3 months, 6 months, 12 months

Study Arms (2)

Single graft corneal transplantation

ACTIVE COMPARATOR

Limbal transplantation combined with central penetrating keratoplasty from single donors.

Procedure: Limbal transplantation combined with central penetrating keratoplasty

Dual graft corneal transplantation

EXPERIMENTAL

Limbal transplantation combined with central penetrating keratoplasty from different donors.

Procedure: Limbal transplantation combined with central penetrating keratoplasty

Interventions

Limbal transplantation combined with central penetrating keratoplastyPROCEDURE

Limbal transplantation combined with central penetrating keratoplasty with single donor cornea

Single graft corneal transplantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Central Study Contacts

Ting Huang, MD, PHD

CONTACT

86-13552338050qingerdong@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 29, 2020

Study Start

August 18, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)