Development and validation of a test facility for pivotal characterization of glaucoma drainage devices

Implant devices for micro invasive glaucoma surgery (MIGS) are gaining increasing acceptance in clinical ophthalmic use. The implant requirements are defined in international standards, such as ANSI Z80.27-2014 and the 2015 Guidance for Industry and Food and Drug Administration Staff “Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices”. The exact fluid-mechanical characterization represents a crucial part of the development and approval of innovative implant devices for MIGS. The current work describes the development and preliminary validation of a versatile test facility for pivotal characterization of glaucoma drainage devices. The test setup enables a pressurization of test specimens by means of two water columns. For measurement of pressure and volume flow, a pressure transducer and a total of three liquid flow meters were implemented into the test setup. Validation was conducted by experimental pressureflow characterization of standardized tubes and a comparison to theoretical results according to Hagen Poiseuille's law for stationary laminar flow of a Newtonian fluid in a tube with a circular cross section. Ultrapure water at (35 ± 2) °C was used for the analyses. The developed test setup potentially enables pressure-flow characterization of test specimens in a wide flow range of 0 μl min-1 ≤ Q ≤ 5.000 μl min-1. The preliminary test facility validation showed a good agreement of measured and theoretical volume flow characteristics as a function of the pressure difference, in the currently investigated flow range of Q < 80 μl min-1. The developed test facility is suitable for pivotal in vitro characterization of glaucoma drainage devices. Future investigations will focus on the final validation of the whole flow range and on the use of the test facility for fluid-mechanical characterization of self-developed prototypes of glaucoma microstents as well as commercially available glaucoma drainage devices.

Conventional glaucoma implants and the new MIGS devices: a comprehensive review of current options and future directions

Glaucoma is a progressive optic neuropathy that is the second leading cause of preventable blindness worldwide, after cataract formation. A rise in the intraocular pressure (IOP) is considered to be a major risk factor for glaucoma and is associated with an abnormal increase of resistance to aqueous humour outflow from the anterior chamber. Glaucoma drainage devices have been developed to provide an alternative pathway through which aqueous humour can effectively exit the anterior chamber, thereby reducing IOP. These devices include the traditional aqueous shunts with tube-plate design, as well as more recent implants, such as the trabeculectomy-modifying EX-PRESS® implant and the new minimally invasive glaucoma surgery (MIGS) devices. In this review, we will describe each implant in detail, focusing on their efficacy in reducing IOP and safety profile. Additionally, a critical and evidence-based comparison between these implants will be provided. Finally, we will propose potential developments that may help to improve the performance of current devices.

Effect of COVID-19 pandemic on glaucoma surgical practices in the UK

Background/AimThe aim of the study was to examine the effect of the COVID-19 pandemic on glaucoma surgical practices within the UK.MethodsA cross-sectional online survey was distributed to all consultant glaucoma specialists who are on the UK and Eire Glaucoma Society contact list. Participants were asked specific questions regarding preferences in glaucoma surgical practices and whether these had changed subsequent to the onset of the COVID-19 pandemic.ResultsTrabeculectomy was the procedure of choice for 61 (87%) glaucoma specialists. A total of 51 (73%) respondents reported performing minimally invasive glaucoma surgery (MIGS) procedures before the COVID-19 pandemic. The most commonly performed MIGS procedure was the iStent inject (51%), followed by XEN 45 (36%) and Preserflo (17%). Forty-three (61%) respondents reported modifying their glaucoma surgery practice subsequent to the onset of the COVID-19 pandemic. Of the glaucoma specialists who modified their surgical practices, 21 (43%) specifically reduced the number of trabeculectomies performed. In combination, diode laser (both micropulse and conventional trans-scleral cyclodiode) was the most common alternative procedure. Glaucoma drainage devices, deep sclerectomy and Preserflo were also commonly chosen alternatives.ConclusionAlthough trabeculectomy remains the most commonly performed established glaucoma surgery, it is being performed with reduced frequency during the COVID-19 pandemic due to the number of postoperative visits and procedures required. Alternatives such as conventional and micropulse diode laser, glaucoma drainage devices, deep sclerectomy and Preserflo appear to be the favoured alternative procedures.

Magnetically Actuated Glaucoma Drainage Device with Adjustable Flow Properties after Implantation

Glaucoma is the second leading cause of preventable blindness worldwide, following cataract formation. A rise in the intraocular pressure (IOP) is a major risk factor for this disease, and results from an elevated resistance to aqueous humor outflow from the anterior chamber of the eye. Glaucoma drainage devices provide an alternative pathway through which the aqueous humor can effectively exit the eye, thereby lowering the IOP. However, post-operative IOP is unpredictable and current implants are deficient in maintaining IOP at optimal levels. To address this deficiency, we are developing an innovative, non-invasive magnetically actuated glaucoma implant with a hydrodynamic resistance that can be adjusted following surgery. This adjustment is achieved by integrating a magnetically actuated microvalve into the implant, which can open or close fluidic channels using an external magnetic stimulus. This microvalve was fabricated from poly(styrene–block–isobutylene–block–styrene), or ‘SIBS’, containing homogeneously dispersed magnetic microparticles. “Micro-pencil” valves of this material were fabricated using a combination of femtosecond laser machining with hot embossing. The glaucoma implant is comprised of a drainage tube and a housing element fabricated from two thermally bonded SIBS layers with the microvalve positioned in between. Microfluidic experiments involving actuating the magnetic micro-pencil with a moving external magnet confirmed the valving function. A pressure difference of around 6 mmHg was achieved, which is sufficient to overcome hypotony (i.e., too low IOP)—one of the most common post-operative complications following glaucoma surgery.

Combined pars plana glaucoma drainage device placement and vitrectomy using a vitrectomy sclerotomy site for tube placement: a case series

Purpose The purpose of this study is to report the safety and efficacy of pars plana glaucoma drainage devices with pars plana vitrectomy using one of the vitrectomy sclerotomy sites for tube placement in patients with refractory glaucoma. Methods Retrospective case series of 28 eyes of 28 patients who underwent combined pars plana glaucoma drainage device and pars plana vitrectomy between November 2016 and September 2019 at Massachusetts Eye and Ear. Main outcome measures were intraocular pressure (IOP), glaucoma medication burden, best corrected visual acuity, and complications. Statistical tests were performed with R and included Kaplan-Meier analyses, Wilcoxon paired signed-rank tests, and Fisher tests. Results Mean IOP decreased from 22.8 mmHg to 11.8 mmHg at 1.5 years (p = 0.002), and mean medication burden decreased from 4.3 to 2.1 at 1.5 years (p = 0.004). Both IOP and medication burden were significantly lower at all follow-up time points. The probability of achieving 5 < IOP ≤ 18 mmHg with at least 20% IOP reduction from preoperative levels was 86.4% at 1 year and 59.8% at 1.5 years. At their last visit, three eyes (10.7%) achieved complete success with IOP reduction as above without medications, and 14 eyes (50.0%) achieved qualified success with medications. Hypotony was observed in 1 eye (3.6%) prior to 3 months postoperatively and 0 eyes after 3 months. Visual acuity was unchanged or improved in 23 eyes (82.1%) at their last follow-up. Two patients had a visual acuity decrease of > 2 lines. Two eyes required subsequent pars plana vitrectomies for tube obstruction, and one eye had transient hypotony. Conclusions The results of pars plana glaucoma drainage device and pars plana vitrectomy using one of the vitrectomy sclerotomy sites for tube placement are promising, resulting in significant IOP and medication-burden reductions through postoperative year 1.5 without additional risk of postoperative complications. Inserting glaucoma drainage devices into an existing vitrectomy sclerotomy site may potentially save surgical time by obviating the need to create another sclerotomy for tube placement and suture one of the vitrectomy ports.