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

• Conditions: Pseudophakic Bullous Keratopathy; Chemical Burn of Cornea; Posterior Polymorphous Corneal Dystrophy; Fuchs Endothelial Corneal Dystrophy

• Registration Number: NCT04387331
• Lead Sponsor: Peter Wiedemann

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 Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-07
• Study Start: 2020-05-11
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• all patients undergoing DMEK

Exclusion Criteria

• no specific exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal Endothelial Cell Density	three months after surgery	measured in cells/mm2

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	prior to surgery, three and six months after surgery	measured in logMAR
Number of Re-Bubblings	six months after surgery	need of surgical intervention after DMEK in order to attach the graft
Corneal Endothelial Density	six months after surgery	measured in cells/mm"
Central Corneal Thickness	prior to surgery, three and six months after surgery	measured in μm

Trial Locations

Locations (1)

Leipzig University Hospital, Department of Ophthalmology; 🇩🇪 Leipzig, Sachsen, Germany