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An aim to provide an optimised keratoprosthesis, with excellent biointegration, and all other properties meeting ideal requirements, is one we share with Mehta et al.1 However, their paper includes some points that require clarification.
PHEMA (poly(2-hydroxyethyl methacrylate) is a non-toxic polymer of the toxic monomer HEMA, though cytotoxicity is still possible if non-reacted monomer has not been fully removed. The “polyhydroxyethyl methacrylate” the authors obtained for their study was not fully described, and may have been contact lens blanks, unlikely to have been processed for “implantable quality.” Whether the samples had been fully extracted was not stated, nor was the hydration of the samples when used for the study. Contact lens blanks are not designed for cell adhesion and the results of this study, with regard to PHEMA, are entirely predictable and have been previously reported.
The commercially available keratoprosthesis AlphaCor is made from a form of PHEMA, specifically modified for its intended purpose within the cornea. In particular, the AlphaCor OPTIC is made from a relatively low water content, but hydrated, microporous form, similar to the samples evaluated by the authors, specifically because it does not encourage cellular adhesion (epithelial coverage is not desired for this model, nor would adherent posterior cells and membranes be desirable).
In contradistinction, the biointegratable SKIRT region of AlphaCor is made from a macroporous form of PHEMA with a very high water content; this material, with its interconnecting channels, has been optimised to promote viable biocolonisation, which has been extensively described in the literature. Mehta et al do concede that cells “may behave differently in colonising a 3-D porous keratoprosthesis skirt”: indeed they do. Further, very subtle modifications of the sponge structure significantly affect all aspects of biointegration.
Both early trial results, such as the preliminary cases cited by Mehta et al, and current results for over 250 AlphaCor devices, have been extensively presented and made available to all device users. Histology now available from AlphaCor devices explanted from human recipients confirms that the biointegration process in humans is similar to that previously shown in the animal model, and maintained in the long term. As expected, specific inflammatory processes can cause localised reversal of biointegration in areas of stromal melting. Certainly, porosity itself does not prevent melting processes, as is also seen in relation to hydroxyapatite keratoprostheses and orbital implants.
There is no argument that keratoprosthesis materials and design require ongoing revision and improvement. The authors’ findings in relation to hydroxyapatite are interesting although, as they note, this rigid material has its own limitations. Novel approaches are undergoing early evaluation and may offer benefits. However, at present, in our view, AlphaCor is a device worthy of consideration for those in whom a donor graft would fail.
CH is medical director of CooperVision Surgical, manufacturer of AlphaCor. The Biomaterials and Polymer Research Department of the Lions Eye Institute has a financial interest in CooperVision Surgical through support of departmental funding, travel, and research.
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