Descemet's Stripping Automated Endothelial KeratoplastyMADENCT03687996
Pratical Assessment of DSAEK in the Management of Endothelial Decompensation Following Penetrating Keratoplasty
An observational study of Descemet's Stripping Automated Endothelial Keratoplasty, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Descemet's Stripping Automated Endothelial Keratoplasty
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Jul 2016
- 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 who profited of the first Descemet's stripping endothelial keratoplasty to endothelial decompensation after penetrating keratoplasty
Who may be able to join
- with endothelial decompensation after penetrating keratoplasty
- surgery realised by the same surgeon
Who cannot join
- None
About this study
Official title: Pratical Assessment of Descemet'Sstripping Automated Endothelial Keratoplasty (DSAEK) in the Management of Endothelial Decompensation Following Penetrating Keratoplasty
Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.
Read the detailed description
A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
pre and postoperative visual acuity in logmar
Measured: change from visual acuity at 6 month
Secondary outcomes (4)
cornea thickness at 6 months
the central cornea and graft thickness measured in OCT
Measured: change from cornea thickness at 6 months
cornea thickness at 10 years
the central cornea and graft thickness measured in OCT
Measured: change from cornea thickness at 10 years
postoperative complications
all the postoperative complications were collected
Measured: month 6
visual acuity at 10 years
pre and postoperative visual acuity in logmar
Measured: change from visual acuity at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Jan 2015
- Primary completion1 Dec 2015
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Descemet's Stripping Automated Endothelial KeratoplastyStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687996
- Sponsor's protocol ID
- 2015-15Obs-CHRMT
- Acronym
- MADE
- Status last verified
- Feb 2023
- First submitted
- 25 Sep 2018
- Last updated
- 3 Feb 2023
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pratical Assessment of Descemet'Sstripping Automated Endothelial Keratoplasty (DSAEK) in the Management of Endothelial Decompensation Following Penetrating Keratoplasty
- ClinicalTrials.gov ID
- NCT03687996
- Acronym / sponsor ID
- MADE / 2015-15Obs-CHRMT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 27 Sep 2018 (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.
Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.
Detailed description
A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who profited of the first Descemet's stripping endothelial keratoplasty to endothelial decompensation after penetrating keratoplasty
Key inclusion criteria (2 listed)
- with endothelial decompensation after penetrating keratoplasty
- surgery realised by the same surgeon
Key exclusion criteria (1 listed)
- None
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
visual acuity
Time frame: change from visual acuity at 6 month
pre and postoperative visual acuity in logmar
4 secondary outcomes
cornea thickness at 6 months
Time frame: change from cornea thickness at 6 months
cornea thickness at 10 years
Time frame: change from cornea thickness at 10 years
postoperative complications
Time frame: month 6
visual acuity at 10 years
Time frame: change from visual acuity at 10 years
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 3 Feb 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Descemet's Stripping Automated Endothelial Keratoplasty, 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 1 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 3 Feb 2023. 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?
visual acuity (time frame: change from visual acuity at 6 month). 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 3 Feb 2023.