Improving the practicality and safety of artificial corneas: Pre-assembly and gamma-rays sterilization of the Boston Keratoprosthesis

González‐Andrades, Miguel; Sharifi, Roholah; Islam, Mohammad Mirazul; Divoux, Thibaut; Haist, Michael; Paschalis, Eleftherios I.; Gelfand, Larisa; Mamodaly, Shamina; Cecilia, Luca Di; Cruzat, Andrea; Ulm, Franz‐Josef; Chodosh, James; Delori, François C.; Dohlman, Claes H.

doi:10.1016/j.jtos.2018.04.002

Cited by 27 publications

(23 citation statements)

References 45 publications

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“…Gamma-irradiation (GI) is already used as sterilization process of human donor corneas as well as of porcine corneas in clinical studies or Boston Keratoprothesis (KPro) and has found to be a promising method to provide a long shelf life of transplants with the elimination of risk of infection (Daoud et al, 2011;Shi et al, 2017;. One disadvantage of using GI is that corneal samples can turned pale yellow and can fail to remain optical clear (Gonzalez-Andrades et al, 2018;Stevenson et al, 2012). Concerning biomechanical properties, using GI can be beneficial, as it was shown that GI enhanced the mechanical stability, tissue hydrophobicity, and resistance to enzymatic degradation in decellularized human cornea tissue (Islam et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

Decellularized human corneal stromal cell sheet as a novel matrix for ocular surface reconstruction

Mertsch

Hasenzahl

Reichl

et al. 2020

J Tissue Eng Regen Med

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The shortage of donor corneas as well as the limitations of tissue substitutes leads to the necessity to develop alternative materials for ocular surface reconstruction. Corneal surface substitutes must fulfill specific requirements such as high transparency, low immunogenicity, and mechanical stability combined with elasticity. This in vitro study evaluates a decellularized matrix secreted from human corneal fibroblasts (HCF) as an alternative material for ocular surface reconstruction. HCF from human donors were cultivated with the supplementation of vitamin C to form a stable and thick matrix. Furthermore, due to enhanced cultivation time, a three‐dimensional like multilayered construct which partly mimics the complex structure of the corneal stroma could be generated. The formed human cell‐based matrices (so‐called cell sheets [CS]) were subsequently decellularized. The complete cell removal, collagen content, ultrastructure, and cell toxicity of the decellularized CS (DCS) as well as biomechanical properties were analyzed. Surgical feasibility was tested on enucleated porcine eyes. After decellularization and sterilization, a transparent, thick, cell free, and sterile tissue substitute resulted, which allowed expansion of limbal epithelial stem cells with no signs of cytotoxicity, and good surgical feasibility. DCS seem to be a promising new corneal tissue substitute derived from human cells without the limitation of donor material; however, future in vivo studies are necessary to further elucidate its potential for ocular surface reconstruction.

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Section: Discussionmentioning

confidence: 99%

Decellularized human corneal stromal cell sheet as a novel matrix for ocular surface reconstruction

Mertsch

Hasenzahl

Reichl

et al. 2020

J Tissue Eng Regen Med

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“…16 Collectively, laboratory and clinical data suggest that targeted immunomodulation may be an important therapeutic adjunct to prevent glaucoma after corneal surgery. 24,25,35 Because clinical studies may take years to conclude, engineering and optical innovations 17,21,27,[41][42][43][44][45][46][47] can be implemented in the meanwhile to improve the overall performance and safety of B-KPro surgery. In this respect, the present study provides valuable information that can aid in improvement in the B-KPro optics.…”

Section: Discussionmentioning

confidence: 99%

Intrinsic Optical Properties of Boston Keratoprosthesis

Hui

Pereira

Dore

et al. 2020

Trans. Vis. Sci. Tech.

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To benchmark the optical performance of Boston Keratoprosthesis (B-KPro). Methods: Back focal lengths (BFL) of B-KPros for various eye axial lengths were measured using an optical bench, International Organization for Standardizationcertified for intraocular lens characterization, and compared against manufacturer's specification. The modulation transfer function (MTF) and the resolution efficiencies were measured. The theoretical geometry-dependent higher-order aberrations (HOA) were calculated. The devices were characterized with optical profilometry for estimating the surface scattering. Aberration correction and subsequent image quality improvement were simulated in CODE-V. Natural scene-imaging was performed in a mock ocular environment. Retrospective analysis of 15 B-KPro recipient eyes were presented to evaluate the possibility of achieving 20/20 best-corrected visual acuity (BCVA). Results: BFL measurements were in excellent agreement with the manufacturerreported values (r = 0.999). The MTF specification exceeded what is required for achieving 20/20 visual acuity. Astigmatism and field curvature, correctable in simulations, were the primary aberrations limiting imaging performance. Profilometry of the anterior surface revealed nanoscale roughness (root-mean-square amplitude, 30-50 nm), contributing negligibly to optical scattering. Images of natural scenes obtained with a simulated B-KPro eye demonstrated good central vision, with 10/10 visual acuity (equivalent to 20/20). Full restoration of 20/20 BCVA was obtainable for over 9 years in some patients. Conclusions: Theoretical and experimental considerations demonstrate that B-KPro has the optical capacity to restore 20/20 BCVA in patients. Further image quality improvement can be anticipated through correction of HOAs. Translational Relevance: We establish an objective benchmark to characterize the optics of the B-KPro and other keratoprosthesis and propose design changes to allow improved vision in B-KPro patients.

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“…92 Furthermore, the sterilization technique by gamma ray radiation has been successfully used as carrier for both BKPro and fresh cornea as well, allowing long-time storage and easy transport at room temperature. 93 Additionally, xenograft transplantation, limited in the past due to risk of graft failure, host immune reaction and cross-species diseases has recently found a renewed interest. Mohammad and colleagues proposed a method to decellularize and sterilize porcine corneas which were then successfully transplanted into rabbit eyes.…”

Section: Future Of Bkpromentioning

confidence: 99%

<p>Boston Type 1 Keratoprosthesis: Updated Perspectives</p>

Nonpassopon¹,

Niparugs²,

Cortina³

2020

OPTH

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The use of Boston type 1 keratoprosthesis (BKPro) has significantly increased worldwide. It is no longer considered a procedure of last resort but a reasonable option for patients with otherwise poor prognosis for a traditional penetrating keratoplasty. BKPro was approved by the Food and Drug Administration in 1992 for bilateral severe corneal blindness due to multiple corneal transplant failure. Over the years, indications have extended beyond recurrent immunologic rejection to include other conditions such as chemical injury and other causes of bilateral limbal stem cell deficiency, extensive corneal neovascularization, neurotrophic corneas and hypotony, among others. Numerous advances in the design of the BKPro, improvement of preoperative, intraoperative and postoperative management have resulted in favorable outcomes and a reduction in postoperative complications. Accordingly, many studies have shown that implantation of this device is highly effective in restoring vision with very good short-term outcomes. However, due to the lifetime risk of sight-threatening complications after BKPro implantation, a longer follow-up period should provide outcomes that are more realistic. In this review, the authors examined only the results of publications with an average of at least 2 years of follow-up. The overall intermediate to long-term visual outcomes and retention rate in BKPro seem to be favorable. However, autoimmune diseases and cicatrizing conditions continue to show a higher incidence of postoperative complications that require further management.

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Improving the practicality and safety of artificial corneas: Pre-assembly and gamma-rays sterilization of the Boston Keratoprosthesis

Cited by 27 publications

References 45 publications

Decellularized human corneal stromal cell sheet as a novel matrix for ocular surface reconstruction

Decellularized human corneal stromal cell sheet as a novel matrix for ocular surface reconstruction

Intrinsic Optical Properties of Boston Keratoprosthesis

<p>Boston Type 1 Keratoprosthesis: Updated Perspectives</p>

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