The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04387331|
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
|Condition or disease|
|Fuchs Endothelial Corneal Dystrophy Pseudophakic Bullous Keratopathy Chemical Burn of Cornea Posterior Polymorphous Corneal Dystrophy|
After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome.
In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK|
|Actual Study Start Date :||May 11, 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
- Corneal Endothelial Cell Density [ Time Frame: three months after surgery ]measured in cells/mm2
- Best Corrected Visual Acuity [ Time Frame: prior to surgery, three and six months after surgery ]measured in logMAR
- Central Corneal Thickness [ Time Frame: prior to surgery, three and six months after surgery ]measured in μm
- Number of Re-Bubblings [ Time Frame: six months after surgery ]need of surgical intervention after DMEK in order to attach the graft
- Corneal Endothelial Density [ Time Frame: six months after surgery ]measured in cells/mm"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387331
|Contact: Christian Girbardt, MDemail@example.com|
|Contact: Louise Kühnefirstname.lastname@example.org|
|Study Director:||Peter Wiedemann, MD||University of Leipzig|