NCT04387331

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

May 7, 2020

Last Update Submit

May 12, 2020

Conditions

Fuchs Endothelial Corneal DystrophyPseudophakic Bullous KeratopathyChemical Burn of CorneaPosterior Polymorphous Corneal Dystrophy

Keywords

Descemet Membrane Endothelial KeratoplastyDMEKFuchs Endothelial Corneal DystrophyPseudophakic Bullous KeratopathyChemical Burn of CorneaPosterior Polymorphous Corneal DystrophyPostoperative Head PositionCorneal TransplantationHead Tracking Sensor

Outcome Measures

Primary Outcomes (1)

  • Corneal Endothelial Cell Density

    measured in cells/mm2

    three months after surgery

Secondary Outcomes (4)

  • Best Corrected Visual Acuity

    prior to surgery, three and six months after surgery

  • Central Corneal Thickness

    prior to surgery, three and six months after surgery

  • Number of Re-Bubblings

    six months after surgery

  • Corneal Endothelial Density

    six months after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • all patients undergoing DMEK

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leipzig University Hospital, Department of Ophthalmology

Leipzig, Saxony, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial DystrophyCorneal Dystrophy, Posterior Polymorphous, 1

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Peter Wiedemann, MD

    University of Leipzig

    STUDY DIRECTOR

Central Study Contacts

Christian Girbardt, MD

CONTACT

00493419721668christian.girbardt@medizin.uni-leipzig.de

Louise Kühne

CONTACT

louise.kuehne@medizin.uni-leipzig.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 13, 2020

Study Start

May 11, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

DE(1)