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

• Sponsor: Peter Wiedemann (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04387331
• Collaborator: Institut für Angewandte Trainingswissenschaft (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• Study Type: Observational
• Anticipated 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
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Outcome Measures

Primary Outcome Measures

1. Corneal Endothelial Cell Density [three months after surgery]

   measured in cells/mm2

Secondary Outcome Measures

1. Best Corrected Visual Acuity [prior to surgery, three and six months after surgery]

   measured in logMAR

2. Central Corneal Thickness [prior to surgery, three and six months after surgery]

   measured in μm

3. Number of Re-Bubblings [six months after surgery]

   need of surgical intervention after DMEK in order to attach the graft

4. Corneal Endothelial Density [six months after surgery]

   measured in cells/mm"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all patients undergoing DMEK

Exclusion Criteria:

• no specific exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leipzig University Hospital, Department of Ophthalmology	Leipzig	Sachsen	Germany	04103

Sponsors and Collaborators

• Peter Wiedemann
• Institut für Angewandte Trainingswissenschaft

Investigators

• Study Director: Peter Wiedemann, MD, University of Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Wiedemann, Director, University of Leipzig
• ClinicalTrials.gov Identifier: NCT04387331
• Other Study ID Numbers: 287/19-ek
• First Posted: May 13, 2020
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Wiedemann, Director, 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: Eye Burns; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy; Burns, Chemical

Study Results

No Results Posted as of May 13, 2020