Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device

Abstract Background Glaucoma is the leading cause of blindness worldwide. Glaucoma drainage devices and minimally invasive glaucoma surgeries (MIGS) often present with tradeoffs in safety and durability of efficacy. Using a rabbit model, we examined the biocompatibility and feasibility of VisiPlate,...

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Autores principales:	Brandon W. Kao, Elana Meer, Thomas A. Barbolt, Richard A. Lewis, Iqbal Ike Ahmed, Vivian Lee, Samuel M. Nicaise, Georgia Griggs, Eydie G. Miller-Ellis
Formato:	article
Lenguaje:	EN
Publicado:	Springer 2021
Materias:	Materials of engineering and construction. Mechanics of materials TA401-492 Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/4f696bcb024446e0b8a59a2846ce1b15
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spelling	oai:doaj.org-article:4f696bcb024446e0b8a59a2846ce1b152021-11-28T12:26:56ZBiocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device10.1007/s10856-021-06613-80957-45301573-4838https://doaj.org/article/4f696bcb024446e0b8a59a2846ce1b152021-11-01T00:00:00Zhttps://doi.org/10.1007/s10856-021-06613-8https://doaj.org/toc/0957-4530https://doaj.org/toc/1573-4838Abstract Background Glaucoma is the leading cause of blindness worldwide. Glaucoma drainage devices and minimally invasive glaucoma surgeries (MIGS) often present with tradeoffs in safety and durability of efficacy. Using a rabbit model, we examined the biocompatibility and feasibility of VisiPlate, a novel, ultrathin, tubeless subconjunctival shunt comprised of a network of microchannels. Methods Six naive female New Zealand White rabbits received implants (three only in the right eye with contralateral eye untreated and three in both eyes) composed of a 400-nm-thick aluminum oxide core coated with 2 µm of parylene-C, manufactured with microelectromechanical systems (MEMS) techniques. Tonometry, slit lamp exam, clinical exam, fluorescein patency testing, and histopathology were performed. Results VisiPlate demonstrated IOP-lowering of 20–40% compared to baseline at each time point over the course of 3 months in the nine implanted eyes. All eyes developed blebs over the implant, and fluorescein testing demonstrated fluid patency at 22 days post-implantation. Slit lamp and clinical observations showed that VisiPlate was well tolerated, with low levels of conjunctival congestion, conjunctival swelling, aqueous flare, hyphema, and iris involvement from surgery that resolved over time. At sacrifice time points of 93 days and 180 days, the only notable observations were mild levels of conjunctival congestion in implanted eyes. Histopathology showed minimal tissue response and no obvious inflammation, fibrosis, or necrosis around the implant. Conclusions The results of this in vivo study demonstrate the biocompatibility and IOP-lowering effect of a multichannel, ultrathin subconjunctival shunt in a rabbit model. The data suggest that VisiPlate may safely enhance aqueous outflow and significantly reduce intraocular pressure.Brandon W. KaoElana MeerThomas A. BarboltRichard A. LewisIqbal Ike AhmedVivian LeeSamuel M. NicaiseGeorgia GriggsEydie G. Miller-EllisSpringerarticleMaterials of engineering and construction. Mechanics of materialsTA401-492Medical technologyR855-855.5ENJournal of Materials Science: Materials in Medicine, Vol 32, Iss 12, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Materials of engineering and construction. Mechanics of materials TA401-492 Medical technology R855-855.5
spellingShingle	Materials of engineering and construction. Mechanics of materials TA401-492 Medical technology R855-855.5 Brandon W. Kao Elana Meer Thomas A. Barbolt Richard A. Lewis Iqbal Ike Ahmed Vivian Lee Samuel M. Nicaise Georgia Griggs Eydie G. Miller-Ellis Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device
description	Abstract Background Glaucoma is the leading cause of blindness worldwide. Glaucoma drainage devices and minimally invasive glaucoma surgeries (MIGS) often present with tradeoffs in safety and durability of efficacy. Using a rabbit model, we examined the biocompatibility and feasibility of VisiPlate, a novel, ultrathin, tubeless subconjunctival shunt comprised of a network of microchannels. Methods Six naive female New Zealand White rabbits received implants (three only in the right eye with contralateral eye untreated and three in both eyes) composed of a 400-nm-thick aluminum oxide core coated with 2 µm of parylene-C, manufactured with microelectromechanical systems (MEMS) techniques. Tonometry, slit lamp exam, clinical exam, fluorescein patency testing, and histopathology were performed. Results VisiPlate demonstrated IOP-lowering of 20–40% compared to baseline at each time point over the course of 3 months in the nine implanted eyes. All eyes developed blebs over the implant, and fluorescein testing demonstrated fluid patency at 22 days post-implantation. Slit lamp and clinical observations showed that VisiPlate was well tolerated, with low levels of conjunctival congestion, conjunctival swelling, aqueous flare, hyphema, and iris involvement from surgery that resolved over time. At sacrifice time points of 93 days and 180 days, the only notable observations were mild levels of conjunctival congestion in implanted eyes. Histopathology showed minimal tissue response and no obvious inflammation, fibrosis, or necrosis around the implant. Conclusions The results of this in vivo study demonstrate the biocompatibility and IOP-lowering effect of a multichannel, ultrathin subconjunctival shunt in a rabbit model. The data suggest that VisiPlate may safely enhance aqueous outflow and significantly reduce intraocular pressure.
format	article
author	Brandon W. Kao Elana Meer Thomas A. Barbolt Richard A. Lewis Iqbal Ike Ahmed Vivian Lee Samuel M. Nicaise Georgia Griggs Eydie G. Miller-Ellis
author_facet	Brandon W. Kao Elana Meer Thomas A. Barbolt Richard A. Lewis Iqbal Ike Ahmed Vivian Lee Samuel M. Nicaise Georgia Griggs Eydie G. Miller-Ellis
author_sort	Brandon W. Kao
title	Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device
title_short	Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device
title_full	Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device
title_fullStr	Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device
title_full_unstemmed	Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device
title_sort	biocompatibility and feasibility of visiplate, a novel ultrathin, multichannel glaucoma drainage device
publisher	Springer
publishDate	2021
url	https://doaj.org/article/4f696bcb024446e0b8a59a2846ce1b15
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Biocompatibility and feasibility of VisiPlate, a novel ultrathin, multichannel glaucoma drainage device

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