Post Operative Visual Acuity for DSAEK and UT-DSAEK (POVIAD)
October 9, 2018 updated by: Centre Hospitalier Régional Metz-Thionville
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
111
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent DSAEK surgery between february 2012 and june 2017
Description
Inclusion Criteria:
- Patients who underwent DSAEK surgery
- Patients in department of ophthalmology between february 2012 and june 2017
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
UT-DSAEK
With graft 6 months thick less than 100 µm
|
All surgeries were performed by the same surgeon and according to the same protocol
|
|
DSAEK
With graft thicker than 100 µm
|
All surgeries were performed by the same surgeon and according to the same protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative visual acuity
Time Frame: Month 6
|
postoperative visual acuity in logmar
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pachymetry
Time Frame: Month 6
|
Measurement of the thickness of the cornea
|
Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2012
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
September 25, 2018
First Submitted That Met QC Criteria
September 25, 2018
First Posted (Actual)
September 26, 2018
Study Record Updates
Last Update Posted (Actual)
October 11, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2017-04Obs-CHRMT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.