Supine positioning for graft attachment after Descemet membrane endothelial keratoplasty: a randomized-controlled trial
Abstract
PURPOSE
The supine positioning for Descemet membrane endothelial keratoplasty attachment (SUPER-DMEK) trial assessed the efficacy of prolonged supine head positioning on graft attachment.
DESIGN
Randomized-controlled trial.
METHODS
Participants with Fuchs' dystrophy were randomized to five days of supine head positioning (intervention) or to one day (control). Participants, surgeons, and investigators were masked until the day after surgery. Adherence to the allocated intervention was monitored using a head sensor. Main outcome measures were area and volume of graft detachment (co-primary endpoints) two weeks after surgery quantified using a validated neural network for image segmentation on anterior segment optical coherence tomography images; repeat air injection (rebubbling), subjective visual function, and adverse events (secondary endpoints).
RESULTS
86 participants received the allocated intervention (35 eyes intervention, 51 eyes control). In the intention-to-treat analysis, the mean area of graft detachment was 28.6% in the intervention arm and 27.5% in the control arm (adjusted between-arm difference, 1.3, 95% CI, -8.7 to 11.4; P = 0.80). Results for volume of detachment and as-treated analyses based on head position sensor data indicated no potentially clinically relevant effect of prolonged supine positioning on graft attachment. Results were not compatible with a relevant treatment effect on rebubbling or subjective visual function. Adverse events, most commonly…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 86 participants or records.
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