SUPER-DMEK: Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty
Study Details
Study Description
Brief Summary
This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 5 days supine positioning Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour. |
Behavioral: Supine positioning: 5 days
Supine positioning for 5 days after DMEK
|
Active Comparator: 1 day supine positioning followed by usual physical activity for 4 days Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour. |
Behavioral: Supine positioning: 1 days
Supine positioning for 1 days after DMEK
|
Outcome Measures
Primary Outcome Measures
- Graft attachment [At two weeks after DMEK]
Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
- Graft attachment [At two weeks after DMEK]
Volume of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Secondary Outcome Measures
- Rebubbling [At two weeks and 3 months after DMEK]
Number of eyes with secondary injection of air after DMEK
- Safety of supine positioning [At two weeks and 3 months after DMEK]
Adverse events (AE) and serious AEs (SAE)
- Subjective visual function [At 3, 12, and 24 months after DMEK]
Subjective visual function on a scale from 0 (worse vision) to 10 (best vision) with higher scores meaning better subjective visual function
- Visual acuity [At 3, 12, and 24 months after DMEK]
Best-corrected visual acuity to determine visual acuity in letters
- Disability glare [At 3, 12, and 24 months after DMEK]
Straylight meter measurement to determine forward scatter in logs straylight parameter
- Graft health: endothelial cell density [At 3, 12, and 24 months after DMEK]
Specular microscopy to determine endothelial cell density
- Graft health [At 12, and 24 months after DMEK]
Slit-lamp exam to identify signs of graft rejection
- Patient-reported visual disability [At 3, 12, and 24 months after DMEK]
The Visual Acuity Factor and Glare Factor of the Visual Function and Corneal Health Status (V-FUCHS) instrument. The instrument's scores are Rasch-analysis based scores expressed in logits. Participants with more difficulty have higher or more positive V-FUCHS scores.
- Corneal edema [At 2 weeks and at 3, 12, and 24 months after DMEK]
Tomography to determine corneal edema in µm
- Corneal backscatter [At 3, 12, and 24 months after DMEK]
Tomography to determine corneal backscatter in scatter units (SU)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
-
Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
Exclusion Criteria:
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Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
-
Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
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Diabetes mellitus with endorgan complications)
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Lack of fixation during corneal tomography
-
Bedridden
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medical Center - University of Freiburg, Eye Hospital | Freiburg | Baden-Wuerttemberg | Germany | 79106 |
Sponsors and Collaborators
- University Eye Hospital, Freiburg
Investigators
- Principal Investigator: Katrin Wacker, MD FEBO, University of Freiburg, Eye Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ETK 22-1101