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

NCT ID: NCT04791696

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-04-01

Brief Summary

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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).

Detailed Description

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Conditions

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Corneal Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent DAIEN, MD, PhD, HDR

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Montpellier

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 35546638 (View on PubMed)

Other Identifiers

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RECHMPL21_0148

Identifier Type: -

Identifier Source: org_study_id

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