Corneal TransplantPOVIADNCT03685851
Post Operative Visual Acuity for DSAEK and UT-DSAEK
An observational study of Corneal Transplant, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
To study the correlation between graft size in DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) and UT (ultra thin)-DSAEK type corneal transplants to the visual acuity 6 months postoperatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Transplant
- What is being tested?
- DSAEK type corneal transplant
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 30 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent DSAEK surgery between february 2012 and june 2017
Who may be able to join
- Patients who underwent DSAEK surgery
- Patients in department of ophthalmology between february 2012 and june 2017
Who cannot join
- None
About this study
Official title: Post Operative Visual Acuity for Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and UT-DSAEK
To study the correlation between graft size in DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) and UT (ultra thin)-DSAEK type corneal transplants to the visual acuity 6 months postoperatively.
- Conditions
- Corneal Transplant
- Being tested
- DSAEK type corneal transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSAEK type corneal transplantProcedure or surgery
All surgeries were performed by the same surgeon and according to the same protocol
| Study group | Role | What they receive |
|---|---|---|
| UT-DSAEK | With graft 6 months thick less than 100 µm Receives: Procedure: DSAEK type corneal transplant | |
| DSAEK | With graft thicker than 100 µm Receives: Procedure: DSAEK type corneal transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual acuity
postoperative visual acuity in logmar
Measured: Month 6
Secondary outcomes (1)
Pachymetry
Measurement of the thickness of the cornea
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Feb 2012
- Primary completion1 Apr 2015
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantStudies 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
- 111 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
- NCT03685851
- Sponsor's protocol ID
- 2017-04Obs-CHRMT
- Acronym
- POVIAD
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 11 Oct 2018
- 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 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Visual Acuity for Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and UT-DSAEK
- ClinicalTrials.gov ID
- NCT03685851
- Acronym / sponsor ID
- POVIAD / 2017-04Obs-CHRMT
- Conditions
- Corneal Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 26 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.
To study the correlation between graft size in DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) and UT (ultra thin)-DSAEK type corneal transplants to the visual acuity 6 months postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UT-DSAEK | – | Procedure: DSAEK type corneal transplantWith graft 6 months thick less than 100 µm |
| DSAEK | – | Procedure: DSAEK type corneal transplantWith graft thicker than 100 µm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent DSAEK surgery between february 2012 and june 2017
Key inclusion criteria (2 listed)
- Patients who underwent DSAEK surgery
- Patients in department of ophthalmology between february 2012 and june 2017
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSAEK type corneal transplantAll surgeries were performed by the same surgeon and according to the same protocol | Procedure or surgery | DSAEK, UT-DSAEK |
Primary outcome
Postoperative visual acuity
Time frame: Month 6
postoperative visual acuity in logmar
1 secondary outcome
Pachymetry
Time frame: Month 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 11 Oct 2018.
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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.
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 Corneal Transplant, 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 11 Oct 2018. 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?
Postoperative visual acuity (time frame: Month 6). 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 Oct 2018.