Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort

March 10, 2021 updated by: University Hospital, Montpellier

Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort, Montpellier, South of France

Keratoplasty is one of the most common grafts and penetrating keratoplasty is still the technique most used in the world, ahead of lamellar grafts, and is estimated to represent 70% of the total.

Graft rejection is still the main cause of failure of this type of surgery, to the extent that nearly a third of all patients will in some way be affected by rejection in due course.

Numerous risk factors for rejection have been identified, whether related to the donor, the recipient, or the surgical procedure itself.

In addition, many of the studies performed have used univariate analysis only, and yet there is a strong case for multivariate analysis, given the wide range of factors that need to be examined.

This study seeks to analyze the rejection rates and the survival of penetrating keratoplasty for a group of patients from Montpellier Hospital (France).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uh Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutives keratoplasty performed in the ophthalmology department of the CHRU (Centre Hospitalier Régional Universitaire) of Montpellier between 15/06/2005 and 18/09/2018, a period of just over 13 years.

Description

Inclusion criteria:

-keratoplasty performed in the ophthalmology department of the CHRU of Montpellier between 15/06/2005 and 18/09/2018

Exclusion criteria:

  • a non-optical graft (tectonic and analgesic graft)
  • lamellar graft (DALK (Deep Anterior Lamellar Keratoplasty) and DSAEK (Descemet Stripping Automated Endothelial Keratoplasty))
  • Silica gel re-dried cornea, duplicates (we included each patient only once per eye)
  • medical record missing from the archives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
graft rejection
Time Frame: 1 day
The main criterion studied is the fact that rejection had occurred, defined by the appearance of a rejection line, whether epithelial or endothelial (Khodadoust line), subepithelial infiltrates, or an anterior chamber inflammatory reaction (Tyndall effect, retro corneal precipitates and Descemet folds) with corneal edema in a previously clear graft. Opaque grafts with no clear period in the 2 weeks after grafting were not considered as rejections, but rather as straightforward graft failures.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
irreversible graft rejection
Time Frame: 1 day
The other criteria studied is irreversible graft rejection, defined as the persistence of a central corneal edema for 3 months despite treatment, and graft failure, defined as a second keratoplasty, or the persistence of a central corneal edema persisting for more than 3 months, whatever the cause (rejection, corneal endothelial cell failure, other).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Vincent DAIEN, MD, PhD, HDR, University Hospitals of Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL21_0148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Transplant Rejection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe