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International Journal of Bioprinting                       Amniotic fornical ring for ocular surface reconstruction



            transplantation (AMT) promotes epithelialization by   conjunctival  sac  sizes.  The  purpose  of  this  retrospective
            facilitating corneal and conjunctival cell migration.   analysis is to collect related material and detailed clinical
            Meanwhile, AMs can secrete several cytokines and inhibit   information from enrolled patients. In particular, we explored
            inflammation, scarring and angiogenesis . Since the   the clinical indications of AFR and compared the outcomes
                                               [2]
            1940s, AM has been most commonly used in ocular surface   with those of SAMT. Moreover, the cost-effectiveness was
            reconstruction due to a variety of diseases, including   analyzed between the SAMT and AFR groups.
            chemical burns, pterygium, ocular surface neoplasia,
            Steven–Johnson syndrome (SJS), and toxic epidermal   2. Materials and methods
            necrolysis (TEN) .
                         [3]
                                                               2.1. Materials
               The AM is only approximately 0.1 mm thick. The AM   PLA 3DP Filament (diameter: 1.75 mm) was purchased
            is so thin that it is prone to intraoperative tears and early   from Sigma-Aldrich (USA). A HORI Z300 PLUS 3D
            postoperative dissolution.  Moreover, prolonged sutures   printer was purchased from Huitianwei Technology Co.,
            can induce conjunctival granulomas. ProKera, which is   Ltd. (Beijing, China). Oxybuprocaine hydrochloride
            a cryopreserved AM that is installed upon polycarbonate   eye drops (0.4%, 20 mL, Santen, Japan) were used as a
            ring systems, has been approved by the United States Food   topical anesthetic. Lidocaine hydrochloride injection (2%,
            and Drug Administration (U.S. FDA) . The advantages of   Sinopharm Ronshyn Pharmaceutical Co., Ltd. China)
                                          [4]
            ProKera over traditional sutured AM are that there is no   was used for infiltration anesthesia. Topical medications,
            need for sutures or operating rooms, and it is easy to insert   including eye gel of deproteinized calf blood extract (20%,
            and remove. Zhou et al. reported that ProKera prolonged   5 g, Shenyang Xingqi Pharmaceutical Co., Ltd.), sodium
            the dissolution time compared with that of sutured   hyaluronate eye drops (0.1%, 10 mL, Germany), levofloxacin
            AMT . If an extensive ocular surface injury occurs,   eye drops (0.5%, Santen, Japan), gatifloxacin eye gel (0.3%,
                [5]
            the AM is required to cover the entire ocular surface,   5 g, Shenyang Xingqi Pharmaceutical Co., Ltd.), TobraDex
            including the cornea, bulbar conjunctiva, palpebral   eye drops (tobramycin 0.3% and dexamethasone 0.1%,
            conjunctiva, conjunctival vault, and palpebral margin.   5 mL, Alcon, USA), TobraDex eye ointment (tobramycin
            However, the ProKera device can only cover the cornea   0.3% and dexamethasone 0.1%, 3.5 g, Alcon, USA), and
            and perilimbal conjunctiva. In addition, edema of the   Tacrolimus eye drops (0.1%, Santen, Japan) were used to
            conjunctiva and eyelids often occurs in the acute stage of   promote epithelial repair, prevent infection, and alleviate
            the disease, resulting in difficult exposure of the operative   inflammation, respectively. A 10-0 nylon suture (Alcon,
            field, prolonging the suture time, and increasing the risk of   USA) was used to secure the amniotic membrane.
            surgery for patients. Therefore, it is necessary to develop
            a new device to facilitate AM fixation in the conjunctival   2.2. Fabrication of sterile AFR
            vault or even cover the eyelid margin.             The 3D-printed AFR was designed with Autodesk 123D
                                                               design software. The STL files were converted to the
               In recent years, three-dimensional printing (3DP)   gcode format using CURA software. PLA filaments were
            technology has been widely applied in medicine and   loaded into the 3D printer, melted at 210°C and extruded
            include implants, medical instruments, prosthetics, and   through a nozzle (0.4 mm) to print layer by layer. The layer
            pharmaceutical  products.  3DP  has enormous potential  in   height and the printing speed were 0.2 mm and 60 mm/s,
            fabricating customized, low-cost, and complex scaffolds .   respectively.  The  wall  thickness  of  the  AFR  is  0.8  mm.
                                                        [6]
            3DP membranes, as an alternative to amniotic membranes,   The transverse and longitudinal diameters of the AFR
            have also been used for ocular surface or conjunctival defect   are based on the size of the patients’ conjunctiva sac. The
            reconstruction . Fused deposition modeling (FDM), which   fabrication of the AFR is illustrated in Figure 1A. The AFR
                       [7]
            is one of the most commonly used 3DPs, is a complex   was sterilized with ethylene oxide before surgery. The acute
            process, including drawing the solid filament into the printer   phase of inflammation often leads to massive exudation in
            head, melting in the heating zone, and extruding through   the conjunctival sac. Therefore, in patients who are in the
            the printer nozzle. FDM has several advantages, including   acute phase, the AFR needs to be partially clipped to leave
            flexibility, having a wide range of materials, being economical,   a gap for exudates to drain (Figure 1A).
            and personalized precision . Polylactic acid (PLA) has
                                  [8]
            become the most frequently utilized 3D-printed material   2.3. Description of technique
            because of its low cost and relatively low melting point.   Ethics approval was obtained from Henan Eye Hospital
            Moreover, it has been approved as a biomedical material   (Permit number: HNEEC-2022(53)).  The institutional
            due to its good biocompatibility . In the present study, we   review board approved a retrospective medical review of
                                     [9]
            fabricated personalized amniotic fornical rings (AFRs) with   patients, who underwent AFR and suture AMT (SAMT)
            PLA materials by 3DP technology according to different   for various ocular surface injuries between January 2019


            Volume 9 Issue 3 (2023)                        331                         https://doi.org/10.18063/ijb.713
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