Biocompatibility of a Novel Microfistula Implant in Nonprimate Mammals for the Surgical Treatment of Glaucoma

Shute, Thomas S.; Dietrich, U.; Baker, Julia F. M.; Carmichael, K. Paige; Wustenberg, William; Ahmed, Iqbal Ike K.; Sheybani, Arsham

doi:10.1167/iovs.16-19453

Cited by 24 publications

(14 citation statements)

References 15 publications

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“…Early clinical and histological studies in animals and humans showed biocompatibility and tolerability without an inflammatory response. 4 , 12 However, tenon dissection performed in unsuccessful cases showed the development of fibrous scar, especially around the stent. 9 Similar to other anterior segment surgeries, although viscoelastic is used in the anterior chamber, turbulent flow of the irrigating solution, MMC toxicity, intracameral hemorrhage, or surgically induced inflammation may cause endothelial cell loss.…”

Section: Discussionmentioning

confidence: 99%

XEN Gel Stent versus trabeculectomy: Short-term effects on corneal endothelial cells

Olgun

Düzgün

Yıldız

et al. 2020

European Journal of Ophthalmology

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Purpose To compare the short-term changes in corneal endothelial cells after trabeculectomy or XEN Gel Stent implantation. Design Prospective, interventional, comparative study. Methods Changes in corneal endothelium in patients that underwent XEN Gel Stent implantation or trabeculectomy were prospectively evaluated. Eighty eyes of 62 diagnosed with open-angle glaucoma were divided into two the trabeculectomy and XEN Gel Stent groups. Corneal specular microscopy was performed at the central cornea using a noncontact specular microscope preoperatively and 3 months after surgery. Results The baseline mean corneal endothelial cell density in the trabeculectomy group was 2390.3 ± 324.8 cells/mm2, and this was significantly reduced to 2148 ± 352.5 cells/mm2 3 months after surgery, representing a cell loss of 10.0% (p < 0.001). The baseline mean corneal endothelial cell density in the XEN Gel Stent group was 2156.2 ±559.7 cells/mm2, and this was significantly reduced to 2098.4 ± 556.2 cells/mm2 3 months after surgery, representing a cell loss of 2.1% (p = 0.002). The corneal endothelial cell density change rate of the trabeculectomy group (−10.0% ± 9.7%) was statistically higher than the XEN Gel Stent group (−2.1% ± 13.8%) (p = 0.002). A statistically significant difference was observed in the trabeculectomy group between the baseline and postoperative values in the coefficient of variation (p = 0.029). Conclusion Trabeculectomy caused more endothelial cell damage than XEN Gel Stent implantation in the short-term follow-up period. The XEN Gel Stent may be the treatment of choice in patients with a significantly low preoperative corneal endothelial cell density.

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Section: Discussionmentioning

confidence: 99%

XEN Gel Stent versus trabeculectomy: Short-term effects on corneal endothelial cells

Olgun

Düzgün

Yıldız

et al. 2020

European Journal of Ophthalmology

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“…This material is used for a variety of medical applications because of its well-established biocompatibility, and it does not cause a foreign-body reaction. 9 ( Figure 1A ).…”

Section: Introductionmentioning

confidence: 99%

XEN glaucoma treatment system in the management of refractory glaucomas: a short review on trial data and potential role in clinical practice

Gregorio

Pedrotti

Stevan

et al. 2018

OPTH

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The recent development of new devices that are significantly less invasive, collectively termed minimally invasive glaucoma surgery, offers new perspective of intraocular pressure reduction with less risk, short operating times, and rapid recovery. The aim of this work is to provide a panoramic review of the currently published clinical data to assess the potential role of XEN gel stent (Allergan PLC, Irvine, CA, USA) in the management of glaucoma, which is the only filtering minimally invasive glaucoma surgery device that allows the subconjunctival filtration. The ab interno placement of the XEN gel stent offers an alternative for lowering intraocular pressure in refractory glaucoma as a final step, and in patients intolerant to medical therapy as an early surgical approach with minimum conjunctival tissue disruption, restricted flow to avoid hypotony, and long-term safety.

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“…Other approved devices and techniques used in human patients include InnFocus MicroShunt ® (InnFocus, Inc), iStent ® (Glaukos ® ), and Gonioscopy‐Assisted Transluminal Trabeculotomy (GATT). The XEN ® Gel Stent (Allergan Plc) is a microfistula implant that consists of a glutaraldehyde cross‐linked porcine gelatin tube that is placed ab interno under direct gonioscopic visualization from the anterior chamber through the trabecular meshwork and sclera into the subconjunctival space; its biocompatibility was successfully tested over 1 year in normal Beagles, but we are not aware of any applications in glaucomatous dogs . Recently, the nanoengineered SalVO/Brown Glaucoma Implant (MicroOptx) was proposed for use in dogs .…”

Section: Novel Surgical Therapies To Control Iopmentioning

confidence: 99%

“…The XEN ® Gel Stent (Allergan Plc) is a microfistula implant that consists of a glutaraldehyde cross-linked porcine gelatin tube that is placed ab interno under direct gonioscopic visualization from the anterior chamber through the trabecular meshwork and sclera into the subconjunctival space; its biocompatibility was successfully tested over 1 year in normal Beagles, but we are not aware of any applications in glaucomatous dogs. 85 Recently, the nanoengineered SalVO/ Brown Glaucoma Implant (MicroOptx) was proposed for use in dogs. 86,87 This MIGS device drains aqueous humor onto the ocular surface, and it was safe and effective to lower IOP in normal Yucatan pigs.…”

Section: Therapies To Control Iopmentioning

confidence: 99%

The future of canine glaucoma therapy

Komàromy

Bras²,

Esson

et al. 2019

Veterinary Ophthalmology

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Canine glaucoma is a group of disorders that are generally associated with increased intraocular pressure (IOP) resulting in a characteristic optic neuropathy. Glaucoma is a leading cause of irreversible vision loss in dogs and may be either primary or secondary. Despite the growing spectrum of medical and surgical therapies, there is no cure, and many affected dogs go blind. Often eyes are enucleated because of painfully high, uncontrollable IOP. While progressive vision loss due to primary glaucoma is considered preventable in some humans, this is mostly not true for dogs. There is an urgent need for more effective, affordable treatment options. Because newly developed glaucoma medications are emerging at a very slow rate and may not be effective in dogs, work toward improving surgical options may be the most rewarding approach in the near term. This Viewpoint Article summarizes the discussions and recommended research strategies of both a Think Tank and a Consortium focused on the development of more effective therapies for canine glaucoma; both were organized and funded by the American College of Veterinary Ophthalmologists Vision for Animals Foundation (ACVO‐VAF). The recommendations consist of (a) better understanding of disease mechanisms, (b) early glaucoma diagnosis and disease staging, (c) optimization of IOP‐lowering medical treatment, (d) new surgical therapies to control IOP, and (e) novel treatment strategies, such as gene and stem cell therapies, neuroprotection, and neuroregeneration. In order to address these needs, increases in research funding specifically focused on canine glaucoma are necessary.

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Biocompatibility of a Novel Microfistula Implant in Nonprimate Mammals for the Surgical Treatment of Glaucoma

Abstract: In nonprimate mammals, the material composing the microfistula implant and the implant itself do not induce significant inflammation or tissue reaction.

Cited by 24 publications

References 15 publications

XEN Gel Stent versus trabeculectomy: Short-term effects on corneal endothelial cells

XEN Gel Stent versus trabeculectomy: Short-term effects on corneal endothelial cells

XEN glaucoma treatment system in the management of refractory glaucomas: a short review on trial data and potential role in clinical practice

The future of canine glaucoma therapy

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