Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty: A Randomized Controlled Trial.

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.

Diurnal Variation in Straylight in Patients With Fuchs Endothelial Corneal Dystrophy and Controls.

PURPOSE: The goal of this study was to investigate diurnal changes in intraocular straylight in relation to other corneal parameters and subjective complaints in patients with Fuchs endothelial dystrophy and healthy controls. METHODS: This is a prospective study conducted in 2 tertiary care hospitals in Germany and the Netherlands. Patients with Fuchs endothelial dystrophy (n = 71) and healthy controls (n = 34) were included. Patients with Fuchs dystrophy were grouped by the presence of subjective complaints and measured over multiple time points during the day. Measurements included intraocular straylight using the C-Quant and corneal thickness and backscatter using a Scheimpflug camera. A separate group of healthy controls was measured intensively with repeated straylight measurements directly after waking. An exponential decay model was used to model the diurnal change. RESULTS: Healthy controls showed an average straylight baseline of 1.17 log(s) with an increase in straylight after waking of 0.22 log(s). In the repeated measurements subgroup, the increase in morning straylight lasted for 22 minutes. Patients with Fuchs dystrophy showed a morning increase in straylight of 0.21 log(s) present up to 4 hours after waking before reaching an average baseline of 1.30 log(s). Straylight was positively correlated with anterior corneal backscatter, r = 0.21, P = 0.022, and corneal thickness, r = 0.46, P < 0.01. CONCLUSIONS: Healthy eyes experience a diurnal straylight increase similar to patients with Fuchs dystrophy in intensity. However, in Fuchs dystrophy, the resolution of increased straylight is prolonged over multiple hours compared with minutes in healthy eyes. This suggests pathological exacerbation of a physiological diurnal change. This mechanism can play a role in subjective complaints experienced by patients with Fuchs dystrophy.

Graft Detachment after Descemet Membrane Endothelial Keratoplasty with and without Cataract Surgery.

Purpose: To evaluate graft detachment after Descemet membrane endothelial keratoplasty (DMEK) in pseudophakic eyes and DMEK combined with cataract surgery (triple DMEK). Design: Analysis of 3 single-center prospective cohort studies and 1 randomized controlled trial. Participants: Participants with Fuchs' endothelial corneal dystrophy. Methods: A validated neural network for image segmentation quantified graft detachment on anterior segment OCT (AS-OCT) images 3 days after DMEK and at the 2-week postoperative visit. Area and volume of graft detachment were compared between DMEK only and triple DMEK using generalized estimating equation models and adjusting for participant age and the size of the air bubble. Main Outcome Measures: Area and volume of DMEK graft detachment. Results: Among 207 participants with 270 eyes included, 75 pseudophakic eyes had DMEK only and 195 eyes had triple DMEK. A total of 147 eyes had less than one third of detachment at day 3. In 139 of these eyes (95%), detachment was still less than one third at the 2-week scan, indicating that postoperative graft detachment at 2 weeks occurred mainly in eyes with early detachment. When superimposing all 3-dimensional maps from 2 weeks after surgery, the central graft was mainly attached and detachment was located at the graft margin. The mean area of graft detachment decreased from 28% in DMEK only and 38% in triple DMEK to 16% in DMEK only and 25% in triple DMEK at the 2-week postoperative visit. At 2 weeks, the mean area of detachment was 1.85-fold higher (95% confidence interval [CI], 1.34-2.56) and the mean volume was 2.41-fold higher (95% CI, 1.51-3.86) in triple DMEK compared with DMEK. A total of 46 eyes received rebubbling procedures, with 7 eyes (9%) in the DMEK group and 39 eyes (20%) in the triple DMEK group (adjusted risk ratio, 3.1; 95% CI, 1.3-7.1), indicating that rebubbling was more common in eyes undergoing triple DMEK. Conclusions: Automated segmentation of AS-OCT images allowed precise quantification of graft detachment over time and identified DMEK combined with cataract surgery as a risk factor. Frequency of operative follow-up might be guided by extent of detachment in the first postoperative days after DMEK.