A Randomized Multicenter Clinical Trial of Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus DSAEK

Dickman, Mor M.; Kruit, Pieter Jan; Remeijer, Lies; Rooij, Jeroen van; Lelij, Allegonda Van der; Wijdh, Robert H J; Biggelaar, Frank J H M van den; Berendschot, Tos T. J. M.; Nuijts, Rudy M.M.A.

doi:10.1016/j.ophtha.2016.07.036

Cited by 104 publications

(136 citation statements)

References 37 publications

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“…The endothelial cell loss (>50%), although higher than average, is comparable with other studies (Dickman et al. ; Ishii et al. ) and normally high in the first year after which cell count stabilizes (Dickman et al.…”

Section: Discussionsupporting

confidence: 89%

Prospective evaluation of clinical outcomes between pre‐cut corneal grafts prepared using a manual or automated technique: with one‐year follow‐up

Muijzer

Luijk

Bogaerdt

et al. 2019

Acta Ophthalmologica

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PurposePosterior lamellar corneal surgery is considered the standard of care for irreversible endothelial cell dysfunction. Pre‐cut grafts can be prepared either manually (Descemet stripping endothelial keratoplasty; DSEK) or mechanically (Descemet stripping automated endothelial keratoplasty; DSAEK). We performed a head‐to‐head clinical comparison between DSEK and DSAEK grafts.MethodsAll DSEK and DSAEK procedures performed by two corneal specialists at the University Medical Center Utrecht from 1 January 2016 through 31 October 2016 were prospectively included. Pre‐cut grafts were delivered by two eye banks, which either exclusively prepared the DSEK or DSAEK grafts. Preoperative and postoperative measurements were obtained, and all surgical events and adverse events were recorded.ResultsA total of 21 DSEK and 53 DSAEK procedures were included for analysis; the two groups were similar at baseline, with the exception of graft endothelial cell density, which was 2531 ± 67 versus 2748 ± 148 cells/mm2, respectively (p < 0.001). At the one‐year follow‐up visit, corrected distance visual acuity and endothelial cell loss were similar between the groups. Mean pachymetry was significantly lower in the DSEK group (521 ± 39 versus 588 ± 59 μm; p < 0.001), whereas the rebubbling rate was significantly higher in the DSEK group (47.6% versus 18.9%; p = 0.001). Finally, three grafts in the DSEK group experienced failure compared to one graft in the DSAEK group (14% versus 1.9%, respectively).ConclusionManually dissected and microkeratome‐dissected grafts performed similarly with respect to vision and endothelial cell loss assessed one year after surgery. The higher incidence of graft failure among manually dissected (i.e. DSEK) grafts may be attributable to reduced relative thickness compared to DSAEK grafts and/or the resulting differences in tissue handling and the surgeon's learning curve.

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Section: Discussionsupporting

confidence: 89%

Prospective evaluation of clinical outcomes between pre‐cut corneal grafts prepared using a manual or automated technique: with one‐year follow‐up

Muijzer

Luijk

Bogaerdt

et al. 2019

Acta Ophthalmologica

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“…Recently, Dickman et al 14 have shown in a multicentric, randomised controlled study that CGT of DSAEK grafts correlates with both speed of visual recovery and final level of visual acuity achieved. The same group had also shown in a previous publication that thinner DSAEK grafts had less irregularities and induced less optical aberrations 15…”

Section: Discussionmentioning

confidence: 99%

Outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) performed in eyes with failure of primary Descemet membrane endothelial keratoplasty (DMEK)

et al. 2018

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“…Methods for preparing precut UT‐DSAEK and DSAEK corneas and numbers of lost donor tissues in both groups were similar (Dickman et al. b). Therefore, cost differences were not expected and previously reported costs were used instead (van den Biggelaar et al.…”

Section: Discussionmentioning

confidence: 99%

“…The study population and study procedures were described previously (Dickman et al. ). Briefly, FED patients who required corneal transplantation due to irreversible corneal endothelial dysfunction were recruited.…”

Section: Methodsmentioning

confidence: 99%

“…Ultrathin Descemet stripping automated endothelial keratoplasty resulted in faster and better visual recovery, with similar hyperopic shift, endothelial cell loss and complication profile (Dickman et al. ). Despite encouraging clinical outcomes, implementation of UT‐DSAEK may be associated with increased costs from a healthcare perspective.…”

Section: Introductionmentioning

confidence: 99%

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Trial‐based cost‐effectiveness analysis of ultrathin Descemet stripping automated endothelial keratoplasty (UT‐DSAEK) versus DSAEK

Simons

Dickman

Biggelaar

et al. 2019

Acta Ophthalmologica

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Purpose: To evaluate the cost-effectiveness of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) versus standard DSAEK.Methods: A cost-effectiveness analysis using data from a multicentre randomized clinical trial was performed. The time horizon was 12 months postoperatively. Sixty-four eyes of 64 patients with Fuchs' endothelial dystrophy were included and randomized to UT-DSAEK (n = 33) or DSAEK (n = 31). Relevant resources from healthcare and societal perspectives were included in the cost analysis. Quality-adjusted life years (QALYs) were determined using the Health Utilities Index Mark 3 questionnaire. The main outcome was the incremental costeffectiveness ratio (ICER; incremental societal costs per QALY).Results: Societal costs were €9431 (US$11 586) for UT-DSAEK and €9110 (US $11 192) for DSAEK. Quality-adjusted life years (QALYs) were 0.74 in both groups. The ICER indicated inferiority of UT-DSAEK. The cost-effectiveness probability ranged from 37% to 42%, assuming the maximum acceptable ICER ranged from €2500-€80 000 (US $3071-US$98 280) per QALY. Additional analyses were performed omitting one UT-DSAEK patient who required a regraft [ICER €9057 (US$11 127) per QALY, costeffectiveness probability: 44-62%] and correcting QALYs for an imbalance in baseline utilities [ICER €23 827 (US$29 271) per QALY, cost-effectiveness probability: 36-59%]. Furthermore, the ICER was €2101 (US$2581) per patient with clinical improvement in best spectacle-corrected visual acuity (≥0.2 logMAR) and €3274 (US$4022) per patient with clinical improvement in National Eye Institute Visual Functioning Questionnaire-25 composite score (≥10 points). Conclusion:The base case analysis favoured DSAEK, since costs of UT-DSAEK were higher while QALYs were comparable. However, additional analyses revealed no preference for UT-DSAEK or DSAEK. Further cost-effectiveness studies are required to reduce uncertainty.

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A Randomized Multicenter Clinical Trial of Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus DSAEK

Abstract: This study indicates that compared with DSAEK, UT-DSAEK results in faster and better recovery of BSCVA with similar refractive outcomes, endothelial cell loss, and incidence of complications.

Cited by 104 publications

References 37 publications

Prospective evaluation of clinical outcomes between pre‐cut corneal grafts prepared using a manual or automated technique: with one‐year follow‐up

Prospective evaluation of clinical outcomes between pre‐cut corneal grafts prepared using a manual or automated technique: with one‐year follow‐up

Outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) performed in eyes with failure of primary Descemet membrane endothelial keratoplasty (DMEK)

Trial‐based cost‐effectiveness analysis of ultrathin Descemet stripping automated endothelial keratoplasty (UT‐DSAEK) versus DSAEK

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