A review of the iStent&amp;reg; trabecular micro-bypass stent: safety and efficacy

Wellik, Sarah R.; Dale, Elena

doi:10.2147/opth.s57217

Cited by 46 publications

(24 citation statements)

References 26 publications

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“…MIGS is intended to achieve lower IOP in patients with glaucoma with shorter surgical time, and ideally to achieve a medication sparing effect. All devices work by increasing the outflow of aqueous humor from the anterior chamber, either by directly accessing Schlemm’s canal 16 – 18 or shunting aqueous humor to the suprachoridal 19 or subconjunctival space. 20 Complications such as hypotony, hyphema, infections of the bleb, revisions of the bleb, and endophthalmitis may occur in up to 35% of patients treated with conventional glaucoma surgery, ie, trabeculectomy (TE).…”

Section: Introductionmentioning

confidence: 99%

Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents

Pillunat¹,

Erb²,

Jünemann³

et al. 2017

OPTH

147

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Over the last decade several novel surgical treatment options and devices for glaucoma have been developed. All these developments aim to cause as little trauma as possible to the eye, to safely, effectively, and sustainably reduce intraocular pressure (IOP), to produce reproducible results, and to be easy to adopt. The term “micro-invasive glaucoma surgery (MIGS)” was used for summarizing all these procedures. Currently MIGS is gaining more and more interest and popularity. The possible reduction of the number of glaucoma medications, the ab interno approach without damaging the conjunctival tissue, and the probably safer procedures compared to incisional surgical methods may explain the increased interest in MIGS. The use of glaucoma drainage implants for lowering IOP in difficult-to-treat patients has been established for a long time, however, a variety of new glaucoma micro-stents are being manufactured by using various materials and are available to increase aqueous outflow via different pathways. This review summarizes published results of randomized clinical studies and extensive case report series on these devices, including Schlemm’s canal stents (iStent®, iStent® inject, Hydrus), suprachoroidal stents (CyPass®, iStent® Supra), and subconjunctival stents (XEN). The article summarizes the findings of published material on efficacy and safety for each of these approaches.

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Section: Introductionmentioning

confidence: 99%

Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents

Pillunat¹,

Erb²,

Jünemann³

et al. 2017

OPTH

147

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“…The suprachoroidal space (SCS) is a potential space found between the sclera and choroid. Due to its close proximity to the ciliary body, choroid, retina, and sclera, this space has recently drawn attention as a site for targeted drug delivery, 1 – 7 placement of glaucoma drainage devices, 8 – 11 and implantation of retinal prostheses. 12 As a site of drug administration, delivery into the SCS is noted for high bioavailability at targeted tissues in posterior segment diseases, as well as fast clearance by the choroidal vasculature.…”

mentioning

confidence: 99%

Thickness and Closure Kinetics of the Suprachoroidal Space Following Microneedle Injection of Liquid Formulations

Chiang

Venugopal

Grossniklaus

et al. 2017

Invest. Ophthalmol. Vis. Sci.

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PurposeTo determine the effect of injection volume and formulation of a microneedle injection into the suprachoroidal space (SCS) on SCS thickness and closure kinetics.MethodsMicroneedle injections containing 25 to 150 μL Hanks' balanced salt solution (HBSS) were performed in the rabbit SCS ex vivo. Distribution of SCS thickness was measured by ultrasonography and three-dimensional (3D) cryo-reconstruction. Microneedle injections were performed in the rabbit SCS in vivo using HBSS, Discovisc, and 1% to 5% carboxymethyl cellulose (CMC) in HBSS. Ultrasonography was used to track SCS thickness over time.ResultsIncreasing HBSS injection volume increased the area of expanded SCS, but did not increase SCS thickness ex vivo. With SCS injections in vivo, the SCS initially expanded to thicknesses of 0.43 ± 0.06 mm with HBSS, 1.5 ± 0.4 mm with Discovisc, and 0.69 to 2.1 mm with 1% to 5% CMC. After injection with HBSS, Discovisc, and 1% CMC solution, the SCS collapsed to baseline with time constants of 19 minutes, 6 hours, and 2.4 days, respectively. In contrast, injections with 3% to 5% CMC solution resulted in SCS expansion to 2.3 to 2.8 mm over the course of 2.8 to 9.1 hours, after which the SCS collapsed to baseline with time constants of 4.5 to 9.2 days.ConclusionsWith low-viscosity formulations, SCS expands to a thickness that remains roughly constant, independent of the volume of fluid injected. Increasing injection fluid viscosity significantly increased SCS thickness. Expansion of the SCS is hypothesized to be controlled by a balance between the viscous forces of the liquid formulation and the resistive biomechanical forces of the tissue.

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“…The Cypass (Transcend[56]) and iStent (Glaukos[57, 58]) micro-stent medical devices are used for lowering IOP in glaucoma refractory to medical therapy. They are surgically implanted within the SCS during cataract surgery using an ab interno approach.…”

Section: Accessing the Suprachoroidal Spacementioning

confidence: 99%

“…These studies also showed dose-sparing with SCS injection compared with eye drops. Micro-stents penetrated through the scleral spur to generate a fluid conduit from the anterior chamber into the SCS have been shown to reduce IOP in glaucoma patients[48, 57, 91]. …”

Section: Pharmacodynamicsmentioning

confidence: 99%

The suprachoroidal space as a route of administration to the posterior segment of the eye

Chiang

Jung

Prausnitz

2018

Advanced Drug Delivery Reviews

102

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The suprachoroidal space (SCS) is a potential space between the sclera and choroid that traverses the circumference of the posterior segment of the eye. The SCS is an attractive site for drug delivery because it targets the choroid, retinal pigment epithelium, and retina with high bioavailability, while maintaining low levels elsewhere in the eye. Indeed, phase III clinical trials are investigating the safety and efficacy of SCS drug delivery. Here, we review the anatomy and physiology of the SCS; methods to access the SCS; kinetics of SCS drug delivery; strategies to target within the SCS; current and potential clinical indications; and the safety and efficacy of this approach in preclinical animal studies and clinical trials.

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A review of the iStent® trabecular micro-bypass stent: safety and efficacy

Cited by 46 publications

References 26 publications

Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents

Micro-invasive glaucoma surgery (MIGS): a review of surgical procedures using stents

Thickness and Closure Kinetics of the Suprachoroidal Space Following Microneedle Injection of Liquid Formulations

The suprachoroidal space as a route of administration to the posterior segment of the eye

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