Predictive Factors of Graft Detachment Following Dmek (PDF DMEKDETACH)
September 7, 2022 updated by: Centre Hospitalier Régional Metz-Thionville
Predictive Factors of Graft Detachment Following Dmek: Retrospective Study About 170 Cases
The aim of this study was to identify the predictive factors of graft detachment after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.
This retrospective study was conducted on patients aged 18 years, with Fuchs' dystrophy (FECD) or pseudophakic bullous keratopathy (PBK), who were scheduled for DMEK or triple-DMEK (combined phacoemulsification and DMEK surgery).
Patients with a history of surgery other than cataract surgery were excluded.
The study was conducted between 2014 and 2022 and follow-up was for 3 months.
The characteristics of patients with and without graft detachment following surgery were compared using logistic regression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
170
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
-
-
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Metz, France, 57085
- CHR Metz-Thionville/Hopital de Mercy
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-
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with fuchs endothelial corneal dystrophy and patients with pseudophakic bullous keratopathies requiring corneal transplantation
Description
Inclusion Criteria:
- Patients over 18 years of age with DMEK surgery
Exclusion Criteria:
- all associated eye surgery other than cataract surgery
- all existing anterior segment anomalies
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
DMEK-operated eyes without graft detachment
Eyes operated with DMEK without graft detachment
|
DMEK-operated eyes
|
|
DMEK-operated with graft detachment
Eyes operated with DMEK with graft detachment
|
DMEK-operated eyes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appearence of the graft on anterior segment optical coherence tomography (AS OCT) examination
Time Frame: up to 3 months after surgery
|
clinical examination and anterior segment optical coherence tomography (AS OCT) examination (appearence of the graft)
|
up to 3 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean-Marc PERONE, MD, CHR Metz Thionville Hopital de Mercy
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)
March 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
September 2, 2022
First Submitted That Met QC Criteria
September 7, 2022
First Posted (Actual)
September 8, 2022
Study Record Updates
Last Update Posted (Actual)
September 8, 2022
Last Update Submitted That Met QC Criteria
September 7, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-10Obs-CHRMT
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.