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

NCT04791696 | Completed

• 1 other identifier: RECHMPL21_0148
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Corneal Transplant Rejection

Keywords

Cornea / surgery; Corneal Transplantation* / adverse effects; Corneal Transplantation* / methods; Graft Rejection / prevention & control; Humans

Outcome Measures

Primary Outcomes (1)

• graft rejection

  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 Outcomes (1)

• irreversible graft rejection

  1 day

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• Debourdeau E, Builles N, Couderc G, Boulhic J, Chamard C, Villain M, Babeau F, Daien V. Risk factors of rejection after penetrating keratoplasty: a retrospective monocentric study. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3627-3638. doi: 10.1007/s00417-022-05691-w. Epub 2022 May 12.

  PMID: 35546638 DERIVED

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Vincent DAIEN, MD, PhD, HDR

  University Hospitals of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

FR (1)