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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04387331

Enrollment

Registered

2020-05-13

Start date

2020-05-11

Completion date

2021-06-30

Last updated

2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Descemet Membrane Endothelial Keratoplasty, DMEK, Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea, Posterior Polymorphous Corneal Dystrophy, Postoperative Head Position, Corneal Transplantation, Head Tracking Sensor

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* all patients undergoing DMEK

Exclusion criteria

* no specific

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Best Corrected Visual Acuity	prior to surgery, three and six months after surgery	measured in logMAR
Central Corneal Thickness	prior to surgery, three and six months after surgery	measured in μm
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

Countries

Germany

Contacts

Primary ContactChristian Girbardt, MD

christian.girbardt@medizin.uni-leipzig.de00493419721668

Backup ContactLouise Kühne

louise.kuehne@medizin.uni-leipzig.de

Outcome results