Corneal Endothelial Cell LossTREKNCT02470793
Technique And Results In Endothelial Keratoplasty
A study testing Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty in people with Corneal Endothelial Cell Loss and Fuchs' Endothelial Dystrophy, run by EDUARD PEDEMONTE-SARRIAS at 1 site in Spain.
Trial summary
To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy
- What is being tested?
- Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.
- Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technique And Results Evaluation In Endothelial Keratoplasty
To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.
- Being tested
- Descemet Stripping Automated Endothelial Keratoplasty, Descemet Membrane Endothelial Keratoplasty
- Keywords
- Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy, Lamellar Keratoplasty, Descemet Stripping Endothelial Keratoplasty, Descemet Membrane Endothelial Keratoplasty, Minimal Surgical Procedure
- Medical subject headings
- Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet Stripping Automated Endothelial KeratoplastyProcedure or surgery
Also called DSAEK, DSEK
Descemet Stripping Automated Endothelial Keratoplasty
Descemet Membrane Endothelial KeratoplastyProcedure or surgery
Also called DMEK
Descemet Membrane Endothelial Keratoplasty
| Study group | Role | What they receive |
|---|---|---|
| DSAEK group | Active comparator | Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty. Receives: Procedure: Descemet Stripping Automated Endothelial Keratoplasty |
| DMEK group | Experimental | Subjects operated of Descemet Membrane Endothelial Keratoplasty. Receives: Procedure: Descemet Membrane Endothelial Keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: First six months postoperatively
Secondary outcomes (3)
Endothelial cell density
Measured: First six months postoperatively
Intraoperative complications
Measured: First six months postoperatively
Postoperative complications
Measured: First six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- EDUARD PEDEMONTE-SARRIAS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, EDUARD PEDEMONTE-SARRIAS, Hospital Mutua de Terrassa
- Investigators
- Eduard Pedemonte-Sarrias, MD, Principal investigator, Hospital Universitari Mútua Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470793
- Sponsor's protocol ID
- 00001
- Acronym
- TREK
- Status last verified
- Mar 2021
- First submitted
- 6 Jun 2015
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technique And Results Evaluation In Endothelial Keratoplasty
- ClinicalTrials.gov ID
- NCT02470793
- Acronym / sponsor ID
- TREK / 00001
- Keywords
- Corneal Endothelial Cell Loss, Fuchs' Endothelial Dystrophy, Lamellar Keratoplasty, Descemet Stripping Endothelial Keratoplasty, Descemet Membrane Endothelial Keratoplasty, Minimal Surgical Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- EDUARD PEDEMONTE-SARRIASUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSAEK group | Active comparator | Procedure: Descemet Stripping Automated Endothelial KeratoplastySubjects operated of Descemet Stripping Automated Endothelial Keratoplasty. |
| DMEK group | Experimental | Procedure: Descemet Membrane Endothelial KeratoplastySubjects operated of Descemet Membrane Endothelial Keratoplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.
- Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.
Key exclusion criteria (1 listed)
- N/A
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 Stripping Automated Endothelial KeratoplastyAlso: DSAEK, DSEKDescemet Stripping Automated Endothelial Keratoplasty | Procedure or surgery | DSAEK group |
| Descemet Membrane Endothelial KeratoplastyAlso: DMEKDescemet Membrane Endothelial Keratoplasty | Procedure or surgery | DMEK group |
Primary outcome
Visual acuity
Time frame: First six months postoperatively
3 secondary outcomes
Endothelial cell density
Time frame: First six months postoperatively
Intraoperative complications
Time frame: First six months postoperatively
Postoperative complications
Time frame: First six months postoperatively
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 11 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Effect of Donor Diabetes and Other Factors on Corneal Transplant Endothelial Cell Loss and Success at 5 Years
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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.
Eduard Pedemonte-Sarrias, MD principal investigator
Hospital Universitari Mútua Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty in people with Corneal Endothelial Cell Loss and Fuchs' Endothelial Dystrophy, run by EDUARD PEDEMONTE-SARRIAS at 1 site in Spain.
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 11 Mar 2021. 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 Spain. 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?
Visual acuity (time frame: First six months postoperatively). 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 11 Mar 2021.