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Preloaded donor corneal lenticules in a new validated 3D printed smart storage glide for Descemet stripping automated endothelial keratoplasty
  1. Alessandro Ruzza1,
  2. Mohit Parekh1,
  3. Stefano Ferrari1,
  4. Gianni Salvalaio1,
  5. Yoav Nahum2,3,
  6. Cristina Bovone2,
  7. Diego Ponzin1,
  8. Massimo Busin2
  1. 1International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Zelarino, Venice, Italy
  2. 2Department of Ophthalmology, Villa Igea Hospital, Forlì, Italy
  3. 3Department of Ophthalmology, Rabin Medical Center, Petah Tikva, Israel
  1. Correspondence to Mohit Parekh, The Veneto Eye Bank Foundation, Padiglione Rama, Via Paccagnella 11, Zelarino, Venice 30174, Italy; mohit.parekh{at}fbov.it

Abstract

Purpose To design and validate the efficacy of three-dimensional (3D) printed smart storage glide (SSG) which is capable of preserving and delivering posterior lenticules for Descemet stripping automated endothelial keratoplasty (DSAEK).

Methods Laboratory investigation (A) was followed by clinical validation (B). Unsuitable corneas for transplantation (n=20) were used for study A. These tissues were cut using a standard microkeratome, punched and loaded into the SSG and preserved for 7 days in transport media. Endothelial cell density (ECD), Trypan blue and Alizarin red staining for endothelial morphology, thickness measurements and glucose uptake, cell apoptosis and immunostaining post preservation were analysed. For study B, clinical grade corneas (n=14) were preloaded in SSG and grafted in patients with indications of Fuchs’ dystrophy (n=8), pseudophakic bullous keratopathy (n=3), posterior polymorphous dystrophy (n=2), and previous DSAEK failure (n=1). Standard DSAEK included descemetorhexis under air and bimanual delivery of the tissue under infusion of buffered saline solution through an anterior chamber maintainer placed at the 12 o’clock position. Main outcome measures for study B were less surgical time, best spectacle-corrected visual acuity (BSCVA), speed of visual recovery, and ECD.

Results For study A, an average ECD loss was 2.30±3.21%, thickness increased by 30.80±20.85% and one-third of glucose was utilised during the preservation phase. Alizarin red showed hexagonality of the cells. Cell apoptosis was not observed and expression of ZO-1 was noted on the preserved tissues. In study B, 25% ECD loss was observed after 6 months. BSCVA improved to 20/25 or better within 3 months after DSAEK. Mean surgical time recorded was 21 min.

Conclusions This paper describes the development, design, laboratory and clinical validation of a 3D printed SSG which helps to store and deliver posterior lenticules, therefore allowing transportation of quality-controlled precut tissues.

  • Cornea
  • Treatment Surgery

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