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 5 days of supine head positioning (intervention) or to 1 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 (coprimary end points) 2 weeks after surgery quantified using a validated neural network for image segmentation on anterior segment optical coherence tomography images, and repeat air injection (rebubbling), subjective visual function, and adverse events (secondary end points).
Results

A total of 86 participants received the allocated intervention (35 eyes intervention and 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 = .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 back pain, were more common and more severe with the intervention.
Conclusions

In this randomized controlled trial, graft attachment was not improved with prolonged supine head positioning. Prolonged supine positioning frequently caused back pain. Prolonged supine positioning after Descemet membrane endothelial keratoplasty for Fuchs’ dystrophy may not be needed in routine practice

Angaben zum Objekt

• Standort: Deutsche Nationalbibliothek Frankfurt am Main
• Umfang: Online-Ressource
• Sprache: Englisch
• Anmerkungen: American journal of ophthalmology. - 263 (2024) , 117-125, ISSN: 1879-1891

Beteiligte, Orts- und Zeitangaben

• Ereignis: Veröffentlichung
• (wo): Freiburg
• (wer): Universität
• (wann): 2023
• Urheber: Kladny, Anne-Marie ; Glatz, Andreas ; Lieberum, Judith-Lisa ; Zander, Daniel ; Siegel, Helena ; Jiang, Jana ; Brandi-Dohrn, Franziska ; Maier, Philip ; Lapp, Thabo ; Lang, Stefan Johann ; Heinzelmann-Mink, Sonja Ute ; Böhringer, Daniel ; Reinhard, Thomas ; Wacker, Katrin

Weitere Informationen

• DOI: 10.1016/j.ajo.2023.11.021
• URN: urn:nbn:de:bsz:25-freidok-2423068
• Rechteinformation: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Letzte Aktualisierung: 25.03.2025, 13:41 MEZ