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

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

Study Overview

• Status: Unknown
• Conditions: Pseudophakic Bullous Keratopathy; Fuchs Endothelial Corneal Dystrophy; 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Christian Girbardt, MD; Phone Number: 00493419721668; Email: christian.girbardt@medizin.uni-leipzig.de
• Study Contact Backup: Name: Louise Kühne; Email: louise.kuehne@medizin.uni-leipzig.de

Study Locations

• Germany
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Recruiting
      • Leipzig University Hospital, Department of Ophthalmology
      • Contact: Christian Girbardt, MD; Phone Number: 00493419721668; Email: christian.girbardt@medizin.uni-leipzig.de
      • Contact: Louise Kühne; Email: louise.kuehne@medizin.uni-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with Descemet Membrane Endothelial Keratoplasty during the study are offered to participate.

Description

Inclusion Criteria:

• all patients undergoing DMEK

Exclusion Criteria:

• no specific exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Endothelial Cell Density	measured in cells/mm2	three months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peter Wiedemann
• Collaborators: Institut für Angewandte Trainingswissenschaft
• Investigators: Study Director: Peter Wiedemann, MD, University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Corneal Transplantation; Descemet Membrane Endothelial Keratoplasty; DMEK; Fuchs Endothelial Corneal Dystrophy; Pseudophakic Bullous Keratopathy; Chemical Burn of Cornea; Posterior Polymorphous Corneal Dystrophy; Postoperative Head Position; Head Tracking Sensor
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Genetic Diseases, Inborn; Craniocerebral Trauma; Trauma, Nervous System; Eye Diseases, Hereditary; Corneal Diseases; Facial Injuries; Burns; Eye Injuries; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy; Eye Burns; Burns, Chemical
• Other Study ID Numbers: 287/19-ek

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No