An interventional study of Supine positioning: 5 days and Supine positioning: 1 days in Fuchs' Endothelial Dystrophy, sponsored by University Eye Hospital, Freiburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by University Eye Hospital, Freiburg · Not applicable, Interventional, and Treatment
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).
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's enrollment of 90 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →University Eye Hospital, Freiburg is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour.
Behavioral: Supine positioning: 5 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 5 days after DMEK
Supine positioning for 1 days after DMEK
Graft attachment
Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Time frame: At two weeks after DMEK
Graft attachment
Volume of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography
Time frame: At two weeks after DMEK
Rebubbling
Number of eyes with secondary injection of air after DMEK
Time frame: At two weeks and 3 months after DMEK
Safety of supine positioning
Adverse events (AE) and serious AEs (SAE)
Time frame: At two weeks and 3 months after DMEK
Subjective visual function
Subjective visual function on a scale from 0 (worse vision) to 10 (best vision) with higher scores meaning better subjective visual function
Time frame: At 3, 12, and 24 months after DMEK
Visual acuity
Best-corrected visual acuity to determine visual acuity in letters
Time frame: At 3, 12, and 24 months after DMEK
Disability glare
Straylight meter measurement to determine forward scatter in logs straylight parameter
Time frame: At 3, 12, and 24 months after DMEK
Graft health: endothelial cell density
Specular microscopy to determine endothelial cell density
Time frame: At 3, 12, and 24 months after DMEK
Graft health
Slit-lamp exam to identify signs of graft rejection
Time frame: At 12, and 24 months after DMEK
Patient-reported visual disability
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.
Time frame: At 3, 12, and 24 months after DMEK
Corneal edema
Tomography to determine corneal edema in µm
Time frame: At 2 weeks and at 3, 12, and 24 months after DMEK
Corneal backscatter
Tomography to determine corneal backscatter in scatter units (SU)
Time frame: At 3, 12, and 24 months after DMEK
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in May 2023, 12 months.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Fuchs' Endothelial Dystrophy →
University Eye Hospital, Freiburg