Preloaded donor corneal lenticules in a new validated 3D printed smart storage glide for Descemet stripping automated endothelial keratoplasty.
OBJECTIVE
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.
International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Zelarino, Venice, Italy.
Alessandro
A
Ruzza
International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Zelarino, Venice, Italy.
Mohit
M
Parekh
International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Zelarino, Venice, Italy.
Stefano
S
Ferrari
International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Zelarino, Venice, Italy.
Gianni
G
Salvalaio
Department of Ophthalmology, Villa Igea Hospital, Forlì, Italy Department of Ophthalmology, Rabin Medical Center, Petah Tikva, Israel.
Yoav
Y
Nahum
Department of Ophthalmology, Villa Igea Hospital, Forlì, Italy.
Cristina
C
Bovone
International Center for Ocular Physiopathology, The Veneto Eye Bank Foundation, Zelarino, Venice, Italy.
Diego
D
Ponzin
Department of Ophthalmology, Villa Igea Hospital, Forlì, Italy.
Massimo
M
Busin
D002102:Cadaver; D003886:Descemet Membrane / Q000033:anatomy & histology* / Q000601:surgery; D057111:Descemet Stripping Endothelial Keratoplasty / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D005642:Fuchs' Endothelial Dystrophy / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D006085:Graft Survival; D006801:Humans; D008297:Male; D008875:Middle Aged; D066330:Printing, Three-Dimensional; D011446:Prospective Studies; D012029:Refraction, Ocular; D013499:Surface Properties; D014019:Tissue Donors; D014792:Visual Acuity
Cornea; Treatment Surgery