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

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ClinicalTrials.gov Identifier: NCT04387331
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Institut für Angewandte Trainingswissenschaft
Information provided by (Responsible Party):
Peter Wiedemann, University of Leipzig

Study Description
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Brief Summary:
This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.

Condition or disease
Fuchs Endothelial Corneal Dystrophy Pseudophakic Bullous Keratopathy Chemical Burn of Cornea Posterior Polymorphous Corneal Dystrophy

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
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Corneal Endothelial Cell Density [ Time Frame: three months after surgery ]
    measured in cells/mm2


Secondary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: prior to surgery, three and six months after surgery ]
    measured in logMAR

  2. Central Corneal Thickness [ Time Frame: prior to surgery, three and six months after surgery ]
    measured in μm

  3. Number of Re-Bubblings [ Time Frame: six months after surgery ]
    need of surgical intervention after DMEK in order to attach the graft

  4. Corneal Endothelial Density [ Time Frame: six months after surgery ]
    measured in cells/mm"


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with Descemet Membrane Endothelial Keratoplasty during the study are offered to participate.
Criteria

Inclusion Criteria:

  • all patients undergoing DMEK

Exclusion Criteria:

  • no specific exclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Christian Girbardt, MD 00493419721668 christian.girbardt@medizin.uni-leipzig.de
Contact: Louise Kühne louise.kuehne@medizin.uni-leipzig.de

Locations
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Germany
Leipzig University Hospital, Department of Ophthalmology Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Christian Girbardt, MD    00493419721668    christian.girbardt@medizin.uni-leipzig.de   
Contact: Louise Kühne       louise.kuehne@medizin.uni-leipzig.de   
Sponsors and Collaborators
Peter Wiedemann
Institut für Angewandte Trainingswissenschaft
Investigators
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Study Director: Peter Wiedemann, MD University of Leipzig
More Information
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Responsible Party: Peter Wiedemann, Director, University of Leipzig
ClinicalTrials.gov Identifier: NCT04387331    
Other Study ID Numbers: 287/19-ek
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Wiedemann, University of Leipzig:
Descemet Membrane Endothelial Keratoplasty
DMEK
Fuchs Endothelial Corneal Dystrophy
Pseudophakic Bullous Keratopathy
Chemical Burn of Cornea
 Posterior Polymorphous Corneal Dystrophy
Postoperative Head Position
Corneal Transplantation
Head Tracking Sensor
Additional relevant MeSH terms:
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Corneal Dystrophies, Hereditary
Fuchs' Endothelial Dystrophy
Burns, Chemical
Corneal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Genetic Diseases, Inborn
Burns
Wounds and Injuries