Frontiers in Ophthalmology (Jan 2023)

Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty

  • Marc B. Muijzer,
  • Heleen Delbeke,
  • Heleen Delbeke,
  • Mor M. Dickman,
  • Rudy M.M.A. Nuijts,
  • Herke Jan Noordmans,
  • Saskia M. Imhof,
  • Robert P. L. Wisse

DOI
https://doi.org/10.3389/fopht.2022.1041778
Journal volume & issue
Vol. 2

Abstract

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ObjectiveTo evaluate if an intraoperative-OCT (iOCT) optimized surgical protocol without prolonged overpressure is non-inferior to a standard protocol during Descemet membrane endothelial keratoplasty (DMEK).MethodsSixty-five pseudophakic eyes of 65 patients with Fuchs endothelial dystrophy scheduled for routine DMEK were recruited in this prospective non-inferiority international multicenter randomized control trial. Subjects were randomized to the control arm (n=33) without iOCT-use and raising the intraocular pressure above normal physiological limits for 8 minutes (i.e., overpressure) or the intervention arm (n=32) with OCT-guidance to assess graft orientation and adherence, while refraining from prolonged overpressure. The primary outcome was the incidence of postoperative surgery-related adverse events (AE). The non-inferiority margin was set at a risk difference of 10%. Secondary outcomes included iOCT-aided surgical decision making, surgical times, and endothelial cell density (ECD) corrected distance visual acuity (CDVA) at 6 months follow-up.ResultsIn the intervention group, 12 subjects developed 13 AEs compared to 13 AEs in 10 subjects in the control group (P=0.644). The risk difference measured -0.32% (95%CI: -10.29 – 9.84). The ECD and CDVA did not differ between the two groups 3 and 6 months postoperatively (P=>0.05). Surgeons reported that iOCT aided surgical decision-making in 40% of cases. Surgery and graft unfolding time were, respectively, 13% and 27% shorter in the iOCT-group.ConclusionsiOCT-guided DMEK surgery with refraining from prolonged over-pressuring was non-inferior compared to conventional treatment. Surgery times were reduced considerably and iOCT aided surgical decision-making in 40% of cases. Refraining from prolonged overpressure did not affect postoperative ECD or CDVA.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03763721 (NCT03763721).

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