Endothelial Corneal DystrophyGOODRMEKNCT04469933
Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)
An observational study of Endothelial Corneal Dystrophy, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD). 82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Corneal Dystrophy
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 May 2018
- 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
- Adult, Older adult
Study population: Included patients' were over 18, had advanced FECD associated with visual symptoms and reduced visual acuity
Who may be able to join
- Over 18,
- had advanced FECD associated with visual symptoms and reduced visual acuity .
Who cannot join
- Prior intraocular surgery other than cataract
- Other indications for DMEK surgeries than FECD,
- Eyes with corneal (except FECD), retinal or optic nerve diseases
- Per-operative difficulties (tear's graft or complicated unfolding graft)
- Primary graft failure (cornea that failed to clear in the presence of an attached graft)
- Secondary graft failure (corneal decompensation after an initial period of a functional graft)
About this study
Official title: Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study About 102 Eyes
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).
82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).
Read the detailed description
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).
A monocentric retrospective observational study was realized at the Regional Hospital Center of Metz-Thionville, Mercy Hospital, Metz, France.
102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery). Surgery was considered successful when best spectacle corrected visual acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively.
- Conditions
- Endothelial Corneal Dystrophy
- Keywords
- Fuchs endothelial corneal dystrophy, central corneal thickness, endothelial cell density, keratometry
- Medical subject headings
- Corneal endothelial dystrophy type 2, Fuchs' Endothelial Dystrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative Central Corneal Thickness (CCT),
Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
Measured: day 1
Post-operative Central Corneal Thickness (CCT),
Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
Measured: Months 12
CCT's delta
CCT's delta (μm) between pre and D15 post-operatively
Measured: day 15
Secondary outcomes (8)
anterior mean keratometry
anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France)
Measured: day 1
pre-operative endothelial cell density ECD
pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)
Measured: day1
post-operative endothelial cell density (ECD)
post-operative ECD at 6 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)
Measured: 6 months
post-operative endothelial cell density (ECD)
post-operative ECD at 12 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)
Measured: 12 months
pre-operative Visual Acuity
pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale)
Measured: day 1
donors' and recipients' ages
donors' and recipients' ages
Measured: day 1
recipients' sex
recipients' sex
Measured: day 1
rate of rebubbling
the rate of rebubbling %(postoperative graft detachment)
Measured: months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 May 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 102 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469933
- Sponsor's protocol ID
- 2020-03ObsCHRMT
- Acronym
- GOODRMEK
- Status last verified
- Jun 2020
- First submitted
- 6 Jul 2020
- Last updated
- 14 Jul 2020
- 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 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study About 102 Eyes
- ClinicalTrials.gov ID
- NCT04469933
- Acronym / sponsor ID
- GOODRMEK / 2020-03ObsCHRMT
- Conditions
- Endothelial Corneal Dystrophy
- Keywords
- Fuchs endothelial corneal dystrophy, central corneal thickness, endothelial cell density, keratometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 14 Jul 2020 (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.
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).
82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).
Detailed description
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).
A monocentric retrospective observational study was realized at the Regional Hospital Center of Metz-Thionville, Mercy Hospital, Metz, France.
102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery). Surgery was considered successful when best spectacle corrected visual acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Included patients' were over 18, had advanced FECD associated with visual symptoms and reduced visual acuity
Key inclusion criteria (2 listed)
- Over 18,
- had advanced FECD associated with visual symptoms and reduced visual acuity .
Key exclusion criteria (6 listed)
- Prior intraocular surgery other than cataract
- Other indications for DMEK surgeries than FECD,
- Eyes with corneal (except FECD), retinal or optic nerve diseases
- Per-operative difficulties (tear's graft or complicated unfolding graft)
- Primary graft failure (cornea that failed to clear in the presence of an attached graft)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-operative Central Corneal Thickness (CCT),
Time frame: day 1
Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
Post-operative Central Corneal Thickness (CCT),
Time frame: Months 12
Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)
CCT's delta
Time frame: day 15
CCT's delta (μm) between pre and D15 post-operatively
8 secondary outcomes
anterior mean keratometry
Time frame: day 1
pre-operative endothelial cell density ECD
Time frame: day1
post-operative endothelial cell density (ECD)
Time frame: 6 months
post-operative endothelial cell density (ECD)
Time frame: 12 months
pre-operative Visual Acuity
Time frame: day 1
donors' and recipients' ages
Time frame: day 1
recipients' sex
Time frame: day 1
rate of rebubbling
Time frame: months 6
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 14 Jul 2020.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Corneal Dystrophy, run by Centre Hospitalier Régional Metz-Thionville.
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 2 inclusion and 6 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Pre-operative Central Corneal Thickness (CCT), (time frame: day 1). The study lists 3 primary outcomes in all. 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 14 Jul 2020.