NCT04791696|Completed
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Sponsor study identifier
observational
200
1 country
1
Study Start
April 1, 2020
Actual (reported)Primary Completion
April 1, 2020
Actual (reported)Study Completion
April 1, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2020
Actual (reported)April 1, 2020
Actual (reported)April 1, 2020
Actual (reported)March 5, 2021
Actual (reported)March 10, 2021
Actual (reported)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
irreversible graft rejection
1 day
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.
UH Montpellier
Montpellier, 34295, France
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.
Vincent DAIEN, MD, PhD, HDR
University Hospitals of Montpellier
200 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2021
First Posted
March 10, 2021
Study Start
April 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 1, 2020
Actual (reported)Study Completion
April 1, 2020
Actual (reported)Last Updated
March 15, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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