The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Peter Wiedemann
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Corneal Endothelial Cell Density
Study Overview
Brief Summary
This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients undergoing DMEK
Exclusion Criteria
- •no specific exclusion criteria
Outcomes
Primary Outcomes
Corneal Endothelial Cell Density
Time Frame: three months after surgery
measured in cells/mm2
Secondary Outcomes
- Best Corrected Visual Acuity(prior to surgery, three and six months after surgery)
- Number of Re-Bubblings(six months after surgery)
- Corneal Endothelial Density(six months after surgery)
- Central Corneal Thickness(prior to surgery, three and six months after surgery)
Investigators
Peter Wiedemann
Director
University of Leipzig