45 research outputs found
Fluid dynamics of a novel micro-fistula implant for the surgical treatment of glaucoma,”
PURPOSE. The purpose of this study was to describe the fluidics of a novel non-valved glaucoma implant designed to prevent hypotony and compare the fluidics of this device with two commonly used non-valved glaucoma devices. METHODS. The XEN 45 micro-fistula implant was designed to limit hypotony by virtue of its length and width according to the Hagen-Poiseuille equation. Flow testing was performed using a syringe pump and pressure transducer at multiple flow rates. The pressure differentials across the XEN implant, the Ex-Press implant, and 10 mm of silicone tubing from a Baerveldt implant at a physiologic flow rate (2.5 lL/min) were extrapolated. RESULTS. The XEN 45 achieved a steady-state pressure calculated at 7.56 mm Hg at 2.5 lL/min. At the same flow rate, the Ex-Press device and Baerveldt tubing reached steady-state pressures of 0.09 and 0.01 mm Hg, respectively. CONCLUSIONS. Under flow testing, the XEN micro-fistula implant was able to maintain backpressure above numerical hypotony levels without the use of complex valve systems. This is due to the XEN implant's design, derived from the principles that dictate Newtonian fluids
Long-term endothelial safety profile with iStent inject in patients with open-angle glaucoma
PURPOSE: To report 5-year postoperative safety data of iStent inject, including overall stability, endothelial cell density (ECD), and endothelial cell loss (ECL) in patients with mild-to-moderate primary open-angle glaucoma (POAG).
DESIGN: 5-year follow-up safety study of the prospective, randomized, single-masked, concurrently controlled, multicenter iStent inject pivotal trial.
METHODS: In this 5-year follow-up safety study of the 2-year iStent inject pivotal randomized controlled trial, patients receiving iStent inject placement and phacoemulsification or phacoemulsification alone were studied for the incidence of clinically relevant complications associated with iStent inject placement and stability. Corneal endothelial endpoints were mean change in ECD from screening and proportion of patients with \u3e30% ECL from screening, from analysis of central specular endothelial images by a central image analysis reading center at several time points through 60 months postoperatively.
RESULTS: Of the 505 original randomized patients, 227 elected to participate (iStent inject and phacoemulsification group, n = 178; phacoemulsification-alone control group, n = 49). No specific device-related adverse events or complications were reported through month 60. No significant differences were observed in mean ECD, mean percentage change in ECD, or proportion of eyes with \u3e30% ECL between the iStent inject and control groups at any time point; mean percentage decrease in ECD at 60 months was 14.3% ± 13.4% in the iStent inject group and 14.8% ± 10.3% in the control group (P = .8112). The annualized rate of ECD change from 3 to 60 months was neither clinically nor statistically significant between groups.
CONCLUSIONS: Implantation of iStent inject during phacoemulsification in patients with mild-to-moderate POAG did not produce any device-related complications or ECD safety concerns compared to phacoemulsification alone through 60 months
New devices in glaucoma
Glaucoma remains a leading cause of blindness globally. Minimally invasive treatment techniques are rapidly expanding the availability of therapeutic options for glaucoma. These include devices aimed at enhancing outflow through the subconjunctival space, Schlemm\u27s canal, and suprachoroidal space, sustained-release drug delivery devices, and extraocular devices aiming to reduce glaucomatous progression through other novel means. In this review, we provide an overview of several novel devices either newly available or in development for the medical and surgical management of glaucoma. Further studies are required to determine the long-term efficacy of these devices and how they will integrate into the current landscape of glaucoma management
Multiple novel prostate cancer susceptibility signals identified by fine-mapping of known risk loci among Europeans
Genome-wide association studies (GWAS) have identified numerous common prostate cancer (PrCa) susceptibility loci. We have
fine-mapped 64 GWAS regions known at the conclusion of the iCOGS study using large-scale genotyping and imputation in
25 723 PrCa cases and 26 274 controls of European ancestry. We detected evidence for multiple independent signals at 16
regions, 12 of which contained additional newly identified significant associations. A single signal comprising a spectrum of
correlated variation was observed at 39 regions; 35 of which are now described by a novel more significantly associated lead SNP,
while the originally reported variant remained as the lead SNP only in 4 regions. We also confirmed two association signals in
Europeans that had been previously reported only in East-Asian GWAS. Based on statistical evidence and linkage disequilibrium
(LD) structure, we have curated and narrowed down the list of the most likely candidate causal variants for each region.
Functional annotation using data from ENCODE filtered for PrCa cell lines and eQTL analysis demonstrated significant
enrichment for overlap with bio-features within this set. By incorporating the novel risk variants identified here alongside the
refined data for existing association signals, we estimate that these loci now explain ∼38.9% of the familial relative risk of PrCa,
an 8.9% improvement over the previously reported GWAS tag SNPs. This suggests that a significant fraction of the heritability of
PrCa may have been hidden during the discovery phase of GWAS, in particular due to the presence of multiple independent
signals within the same regio
Phaco-endocycloplasty: A novel technique for management of ring iridociliary cyst presenting as acute angle closure
Iridociliary cysts of pigment epithelium are rare, ring cysts being rarer still, and usually benign in their clinical course. Presented here is a case of ring iridociliary cyst that resulted in secondary synechial angle closure with an acutely elevated intraocular pressure, refractory to medical treatment. Primary endocycloplasty and cataract extraction with implant were used successfully to manage the case
Recommendations for the management of elevated intraocular pressure due to bleb fibrosis after XEN gel stent implantation
Surgical management of glaucoma offers a means of effective disease control. A gel stent that facilitates drainage to the subconjunctival space offers intraocular pressure (IOP) reduction similar to traditional glaucoma filtering surgeries in a less invasive manner. However, like all subconjunctival filtering procedures that result in a bleb, fibrosis can present as a cause of elevated IOP. The following proposed techniques and recommendations for managing elevated IOP due to bleb fibrosis after gel stent implantation are based on the clinical experience of the authors. The goal of this paper is to improve outcomes following gel stent surgery by providing guidance on assessment of bleb function and strategies for bleb enhancement.status: publishe
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PRESERFLO MicroShunt - 7
The PRESERFLO® MicroShunt (Santen Pharmaceutical Co. Ltd., Osaka, Japan), formerly called the InnFocus MicroShunt®, is a trans-scleral device that shunts aqueous humour from the anterior chamber to a filtering bleb under the conjunctiva and Tenon’s capsule. Manufactured from an inert biocompatible material called poly(styrene-block-isobutylene-block-styrene), or ‘SIBS’, the device elicits minimal foreign body reaction and inflammation; potentially reducing the risk of bleb-related fibrosis and failure. The MicroShunt is 8.5 mm long with a 70 μm lumen and is designed to minimize hypotony based on the Hagen–Poiseuille equation. Inserted via an ab-externo approach, the MicroShunt eliminates the need for creation of a scleral flap, sclerostomy, iridectomy, scleral flap suturing and postoperative suture lysis. Clinical trials show promising results with the MicroShunt achieving intraocular pressure reduction approaching that of trabeculectomy, the current gold standard for treating refractory glaucoma