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

Pseudophakic Bullous Keratopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387331
• Other study ID #: 287/19-ek
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: June 2021

Study information

• Verified date: May 2020
• Source: University of Leipzig
• Contact: Christian Girbardt, MD
• Phone: 00493419721668
• Email: christian.girbardt[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients undergoing DMEK

Exclusion Criteria:

• no specific exclusion criteria

Related Conditions & MeSH terms

• Chemical Burn of Cornea
• Corneal Dystrophies, Hereditary
• Fuchs Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy
• Posterior Polymorphous Corneal Dystrophy
• Pseudophakic Bullous Keratopathy

Locations

Country	Name	City	State
Germany	Leipzig University Hospital, Department of Ophthalmology	Leipzig	Sachsen

Sponsors (2)

Lead Sponsor	Collaborator
Peter Wiedemann	Institut für Angewandte Trainingswissenschaft

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Endothelial Cell Density	measured in cells/mm2	three months after surgery
Secondary	Best Corrected Visual Acuity	measured in logMAR	prior to surgery, three and six months after surgery
Secondary	Central Corneal Thickness	measured in µm	prior to surgery, three and six months after surgery
Secondary	Number of Re-Bubblings	need of surgical intervention after DMEK in order to attach the graft	six months after surgery
Secondary	Corneal Endothelial Density	measured in cells/mm"	six months after surgery