Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty
- Conditions
- Fuchs' Endothelial Dystrophy
- Registration Number
- NCT05399095
- Lead Sponsor
- University Eye Hospital, Freiburg
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
- Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
- 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)
- Diabetes mellitus with endorgan complications)
- Lack of fixation during corneal tomography
- Bedridden
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Safety of supine positioning At two weeks and 3 months after DMEK Adverse events (AE) and serious AEs (SAE)
Disability glare At 3, 12, and 24 months after DMEK Straylight meter measurement to determine forward scatter in logs straylight parameter
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
Graft health: endothelial cell density At 3, 12, and 24 months after DMEK Specular microscopy to determine endothelial cell density
Rebubbling At two weeks and 3 months after DMEK Number of eyes with secondary injection of air after DMEK
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 backscatter At 3, 12, and 24 months after DMEK Tomography to determine corneal backscatter in scatter units (SU)
Corneal edema At 2 weeks and at 3, 12, and 24 months after DMEK Tomography to determine corneal edema in µm
Trial Locations
- Locations (1)
Medical Center - University of Freiburg, Eye Hospital
🇩🇪Freiburg, Baden-Wuerttemberg, Germany