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

NCT ID: NCT04387331

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-11

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* all patients undergoing DMEK
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Angewandte Trainingswissenschaft

UNKNOWN

Sponsor Role collaborator

Peter Wiedemann

OTHER

Sponsor Role lead

Responsible Party

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Peter Wiedemann

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peter Wiedemann, MD

Role: STUDY_DIRECTOR

University of Leipzig

Locations

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Leipzig University Hospital, Department of Ophthalmology

Leipzig, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Girbardt, MD

Role: CONTACT

00493419721668

Louise Kühne

Role: CONTACT

Facility Contacts

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Christian Girbardt, MD

Role: primary

00493419721668

Louise Kühne

Role: backup

Other Identifiers

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287/19-ek

Identifier Type: -

Identifier Source: org_study_id

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