The fully synthetic, bio-coated MIRO® CORNEA UR keratoprosthesis: development, preclinical testing, and first clinical results

Duncker, G.; Storsberg, Joachim; Müller-Lierheim, Wolfgang G.K.

doi:10.1007/s00717-014-0243-4

Cited by 18 publications

(3 citation statements)

References 18 publications

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“…Soft skirt materials have been adopted in recent years to increase biointegration based on a variety of synthetic polymers with or without biofunctionalisation with macromolecules ( Table 3 ). Several skirt and optic type KPros have been brought to clinical trials over the decades, including the Keraklear ( 94 ), the MIRO ® Cornea ( 95 ), the Legeais BioKpro III ( 96 ) and the Korea Seoul-type KPro ( 99 , 100 ). However, for the purpose of this review, we will focus on the AlphaCor™ keratoprosthesis, the first soft KPro to obtain FDA approval almost 20 years ago, while mentioning the two newest soft synthetic KPros that have begun clinical trials in the last year (CorNeat, and EndoArt).…”

Section: Soft Keratoprosthesesmentioning

confidence: 99%

Artificial Cornea: Past, Current, and Future Directions

et al. 2021

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Corneal diseases are a leading cause of blindness with an estimated 10 million patients diagnosed with bilateral corneal blindness worldwide. Corneal transplantation is highly successful in low-risk patients with corneal blindness but often fails those with high-risk indications such as recurrent or chronic inflammatory disorders, history of glaucoma and herpetic infections, and those with neovascularisation of the host bed. Moreover, the need for donor corneas greatly exceeds the supply, especially in disadvantaged countries. Therefore, artificial and bio-mimetic corneas have been investigated for patients with indications that result in keratoplasty failure. Two long-lasting keratoprostheses with different indications, the Boston type-1 keratoprostheses and osteo-odonto-keratoprostheses have been adapted to minimise complications that have arisen over time. However, both utilise either autologous tissue or an allograft cornea to increase biointegration. To step away from the need for donor material, synthetic keratoprostheses with soft skirts have been introduced to increase biointegration between the device and native tissue. The AlphaCor™, a synthetic polymer (PHEMA) hydrogel, addressed certain complications of the previous versions of keratoprostheses but resulted in stromal melting and optic deposition. Efforts are being made towards creating synthetic keratoprostheses that emulate native corneas by the inclusion of biomolecules that support enhanced biointegration of the implant while reducing stromal melting and optic deposition. The field continues to shift towards more advanced bioengineering approaches to form replacement corneas. Certain biomolecules such as collagen are being investigated to create corneal substitutes, which can be used as the basis for bio-inks in 3D corneal bioprinting. Alternatively, decellularised corneas from mammalian sources have shown potential in replicating both the corneal composition and fibril architecture. This review will discuss the limitations of keratoplasty, milestones in the history of artificial corneal development, advancements in current artificial corneas, and future possibilities in this field.

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Section: Soft Keratoprosthesesmentioning

confidence: 99%

Artificial Cornea: Past, Current, and Future Directions

et al. 2021

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“…Only Duncker et al have so far reported the outcomes of an acrylate polymeric KPro implanted as a synthetic OOKP replacement in humans. 58 However the material suffered surface spoilation and required surface modification for biointegration. The durability of the OOKP lamina is attributed to the strength and stability of the alveo-dental laminal tissue.…”

Section: Introductionmentioning

confidence: 99%

Biomimetic bone-like composites as osteo-odonto-keratoprosthesis skirt substitutes

et al. 2020

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Osteo-odonto-keratoprostheses, incorporating dental laminate material as an anchoring skirt around a central poly(methyl methacrylate) (PMMA) optic, have been used to replace the cornea for many years. However, there are many intricacies associated with the use of autologous dental laminate material, surgical complexity and skirt erosion. Tissue engineering approaches to bone replacement may offer suitable alternatives in osteo-odonto-keratoprosthesis (OOKP) surgery. In this study, a hydrogel polymer composite was investigated as a synthetic substitute for the OOKP skirt. A novel high strength interpenetrating network (IPN) hydrogel composite with nano-crystalline hydroxyapatite (nHAp) coated poly (lactic-co-glycolic acid) PLGA microspheres was created to mimic the alveo-dental lamina by employing agarose and poly(ethylene glycol) diacrylate (PEGDA) polymers. The incorporation of nHAp coated PLGA microspheres into the hybrid IPN network provide a micro-environment similar to that of skeletal tissues and improve cellular response. Agarose was used as a first network to encapsulate keratocytes/3T3 fibroblasts and PEGDA (6000 Da) was used as a second network with varying concentrations (20 and 40 wt %) to produce a strong and biocompatible scaffold. An increased concentration of either agarose or PEG-DA and incorporation of nHAp coated PLGA microspheres led to an increase in the elastic modulus. The IPN hydrogel combinations supported the adhesion and proliferation of both fibroblast and ocular human keratocyte cell types during in in-vitro testing. The cells endured the encapsulation process into the IPN and remained viable at 1 week post-encapsulation in the presence of nHAp coated microspheres. The material did not induce significant production of inflammatory cytokine IL-6 in comparison to a positive control ( p < 0.05) indicating non-inflammatory potential. The nHAp encapsulated composite IPN hydrogels are mechanically strong, cell supportive, non-inflammatory materials supporting their development as OOKP skirt substitutes using a new approach to dental laminate biomimicry in the OOKP skirt material.

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“…Presently, there are three keratoprosthesis with a widespread use in humans: the Boston keratoprosthesis (B-KPro) [ 9 , 10 ], the osteo-odonto-keratoprosthesis (OOKP) [ 11 , 12 , 13 ], and the so-called MICOF (Moscow eye microsurgery complex in Russia) [ 14 , 15 ]. Likewise, newer designs are recently strongly emerging, such as the KeraKlear ® (Keramed) [ 16 , 17 ], the Miro Cornea ® [ 17 , 18 ], and the Alphacor [ 19 , 20 ]. However, while the first two have presented promising initial results despite a very short follow up, the latter has been recently discontinued after developing severe mid- and long-term complications.…”

Section: Introductionmentioning

confidence: 99%

Keratoprosthesis: A Review of Recent Advances in the Field

Salvador-Culla

Kolovou

2016

JFB

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Since its discovery in the years of the French Revolution, the field of keratoprostheses has evolved significantly. However, the path towards its present state has not always been an easy one. Initially discarded for its devastating complications, the introduction of new materials and the discovery of antibiotics in the last century gave new life to the field. Since then, the use of keratoprostheses for severe ocular surface disorders and corneal opacities has increased significantly, to the point that it has become a standard procedure for corneal specialists worldwide. Although the rate of complications has significantly been reduced, these can impede the long-term success, since some of them can be visually devastating. In an attempt to overcome these complications, researchers in the field have been recently working on improving the design of the currently available devices, by introducing the use of new materials that are more biocompatible with the eye. Here we present an update on the most recent research in the field.

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The fully synthetic, bio-coated MIRO® CORNEA UR keratoprosthesis: development, preclinical testing, and first clinical results

Cited by 18 publications

References 18 publications

Artificial Cornea: Past, Current, and Future Directions

Artificial Cornea: Past, Current, and Future Directions

Biomimetic bone-like composites as osteo-odonto-keratoprosthesis skirt substitutes

Keratoprosthesis: A Review of Recent Advances in the Field

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