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A Prospective, Randomized Trial of DSAEK Outcomes Comparing Different Donor Preparation Devices
W. Barry Lee, MD, Bryan E. Lusk, MD, Michael J. Lynn, MS
endothelial keratoplasty, DSAEK, microkeratome, precut tissue
PURPOSE: To determine whether Descemet stripping automated endothelial keratoplasty (DSAEK) outcomes differ between precut or surgeon-cut donor tissue and the Horizon or Moria systems.
DESIGN: This study was a randomized, prospective, double-masked clinical trial.
METHODS: Sixty-three consecutive DSAEK surgeries underwent tissue randomization. Thirty-three eyes underwent DSAEK using precut donor tissue prepared with the Horizon system (Group 1) and 30 eyes underwent DSAEK using tissue prepared by the surgeon with the Moria system (Group 2). Main outcome measures included visual acuity, mean endothelial cell loss, graft clarity, and complication rates.
RESULTS: The mean patient age was 70 +/- 10 (range, 55-87), with 52 eyes (83%) having Fuchs endothelial corneal dystrophy and 11 eyes (17%) with pseudophakic bullous keratopathy. Mean preoperative best spectacle-corrected visual acuity (BSCVA) was 20/96 (0.68) in Group 1 and 20/130 (0.81) in Group 2 (p value =0.19), and the mean postoperative BSCVA was 20/39 (0.29) in Group 1 and 20/47 (0.37) in Group 2 (p value = 0.25). Mean endothelial cell loss at 12 months was 30.9% in Group 1 and 28.2% in Group 2 (p value = 0.28). Mean induced astigmatism at 6 months was -0.01D in Group 1 and 0.17D in Group 2 (P = 0.59). Group 1 had 3 (9.1%) tissue dislocations and Group 2 had 2 (6.5%) tissue dislocations (P = 0.1). Group 1 had 1 (3.0%) primary graft failure (PGF) and Group 2 had none (P = 0.1). Endothelial graft rejection and pupil block glaucoma were not observed.
CONCLUSIONS: No statistical difference was observed in DSAEK outcomes regardless of whether the tissue was precut or surgeon-cut or whether prepared by the Horizon or Moria devices.
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