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Clinical Trials/NCT04387331
NCT04387331
Unknown
Not Applicable

The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK

Peter Wiedemann1 site in 1 country50 target enrollmentMay 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fuchs Endothelial Corneal Dystrophy
Sponsor
Peter Wiedemann
Enrollment
50
Locations
1
Primary Endpoint
Corneal Endothelial Cell Density
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2020
End Date
June 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Peter Wiedemann

Director

University of Leipzig

Eligibility Criteria

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)

Study Sites (1)

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