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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 days supine positioning | Experimental | Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour. |
|
| 1 day supine positioning followed by usual physical activity for 4 days | Active Comparator | Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine positioning: 5 days | Behavioral | Supine positioning for 5 days after DMEK |
|
| Measure | Description | Time Frame |
|---|---|---|
| Graft attachment | Area of graft detachment, quantified from a trained and validated neural network for image segmentation of anterior segment optical coherence tomography | 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 | At two weeks after DMEK |
| Measure | Description | Time Frame |
|---|---|---|
| Rebubbling | Number of eyes with secondary injection of air after DMEK | At two weeks and 3 months after DMEK |
| Safety of supine positioning | Adverse events (AE) and serious AEs (SAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrin Wacker, MD FEBO | University of Freiburg, Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center - University of Freiburg, Eye Hospital | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
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| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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Stratification will be performed according to the surgical procedure (DMEK alone or DMEK combined cataract surgery). Within each strata, participants will be randomized in a 1:1 ratio to 5 days (intervention) and 1 day (control) postoperative supine positioning.
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Participants, care providers, surgeons, and investigators will be masked until the first postoperative day after DMEK. Investigators will open the opaque envelope with the study assignment together with the participant and inform care providers on the positioning regimen for the next 4 days.
The primary outcome will be assessed by a masked investigator using a trained and validated neural network for image segmentation.
| Supine positioning: 1 days | Behavioral | Supine positioning for 1 days after DMEK |
|
| 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 | At 3, 12, and 24 months after DMEK |
| Visual acuity | Best-corrected visual acuity to determine visual acuity in letters | At 3, 12, and 24 months after DMEK |
| Disability glare | Straylight meter measurement to determine forward scatter in logs straylight parameter | At 3, 12, and 24 months after DMEK |
| Graft health: endothelial cell density | Specular microscopy to determine endothelial cell density | At 3, 12, and 24 months after DMEK |
| Graft health | Slit-lamp exam to identify signs of graft rejection | 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. | At 3, 12, and 24 months after DMEK |
| Corneal edema | Tomography to determine corneal edema in µm | At 2 weeks and at 3, 12, and 24 months after DMEK |
| Corneal backscatter | Tomography to determine corneal backscatter in scatter units (SU) | At 3, 12, and 24 months after DMEK |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |