Fuchs' Endothelial Corneal DystrophyPDF DMEKDETACHNCT05531760
Predictive Factors of Graft Detachment Following Dmek
An observational study of Fuchs' Endothelial Corneal Dystrophy and Descemet Membrane Endothelial Keratoplasty, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Corneal Dystrophy, Descemet Membrane Endothelial Keratoplasty, Pseudophakic Bullous Keratopathy
- What is being tested?
- Descemet Membrane Endothelial Keratoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with fuchs endothelial corneal dystrophy and patients with pseudophakic bullous keratopathies requiring corneal transplantation
Who may be able to join
- Patients over 18 years of age with DMEK surgery
Who cannot join
- all associated eye surgery other than cataract surgery
- all existing anterior segment anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fuchs' Endothelial Corneal Dystrophy, Descemet Membrane Endothelial Keratoplasty, Pseudophakic Bullous Keratopathy, Graft Detachment
- Being tested
- Descemet Membrane Endothelial Keratoplasty
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet Membrane Endothelial KeratoplastyProcedure or surgery
DMEK-operated eyes
| Study group | Role | What they receive |
|---|---|---|
| DMEK-operated eyes without graft detachment | Eyes operated with DMEK without graft detachment Receives: Procedure: Descemet Membrane Endothelial Keratoplasty | |
| DMEK-operated with graft detachment | Eyes operated with DMEK with graft detachment Receives: Procedure: Descemet Membrane Endothelial Keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearence of the graft on anterior segment optical coherence tomography (AS OCT) examination
clinical examination and anterior segment optical coherence tomography (AS OCT) examination (appearence of the graft)
Measured: up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial Corneal DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc PERONE, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531760
- Sponsor's protocol ID
- 2022-10Obs-CHRMT
- Acronym
- PDF DMEKDETACH
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Graft Detachment Following Dmek: Retrospective Study About 170 Cases
- ClinicalTrials.gov ID
- NCT05531760
- Acronym / sponsor ID
- PDF DMEKDETACH / 2022-10Obs-CHRMT
- Conditions
- Fuchs' Endothelial Corneal Dystrophy, Descemet Membrane Endothelial Keratoplasty, Pseudophakic Bullous Keratopathy, Graft Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMEK-operated eyes without graft detachment | – | Procedure: Descemet Membrane Endothelial KeratoplastyEyes operated with DMEK without graft detachment |
| DMEK-operated with graft detachment | – | Procedure: Descemet Membrane Endothelial KeratoplastyEyes operated with DMEK with graft detachment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fuchs endothelial corneal dystrophy and patients with pseudophakic bullous keratopathies requiring corneal transplantation
Key inclusion criteria (1 listed)
- Patients over 18 years of age with DMEK surgery
Key exclusion criteria (2 listed)
- all associated eye surgery other than cataract surgery
- all existing anterior segment anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descemet Membrane Endothelial KeratoplastyDMEK-operated eyes | Procedure or surgery | DMEK-operated eyes without graft detachment, DMEK-operated with graft detachment |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
Related trials for Fuchs' Endothelial Corneal Dystrophy
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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The Belgian Endothelial Surgical Transplant of the Cornea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc PERONE, MD principal investigator
CHR Metz Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fuchs' Endothelial Corneal Dystrophy and Descemet Membrane Endothelial Keratoplasty, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearence of the graft on anterior segment optical coherence tomography (AS OCT) examination (time frame: up to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.