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The New Era of Glaucoma Micro-stent Surgery.

ABSTRACT: Minimally invasive glaucoma surgery (MIGS) has been gaining popularity over the last decade. Although there is no strict definition for MIGS, all the new procedures share the common theme of intraocular pressure reduction with minimal tissue destruction, short surgical time, simple instrumentation and fast postoperative recovery. The use of glaucoma drainage implants has long been the traditional treatment for complex glaucoma, but a new wave of glaucoma micro-stents are now being manufactured with various materials designed to increase aqueous outflow via different channels. This review summarises the current published literature on these devices, including Sclemm's canal stents (iStent, Hydrus), Suprachoroidal stents (CyPass, iStent supra), and subconjunctival stents (Xen, Innfocus).

SUBMITTER: Manasses DT

PROVIDER: S-EPMC5125116 | biostudies-other | 2016 Dec

REPOSITORIES: biostudies-other

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The New Era of Glaucoma Micro-stent Surgery.

Manasses Demetrios T DT Au Leon L

Ophthalmology and therapy 20160617 2

Minimally invasive glaucoma surgery (MIGS) has been gaining popularity over the last decade. Although there is no strict definition for MIGS, all the new procedures share the common theme of intraocular pressure reduction with minimal tissue destruction, short surgical time, simple instrumentation and fast postoperative recovery. The use of glaucoma drainage implants has long been the traditional treatment for complex glaucoma, but a new wave of glaucoma micro-stents are now being manufactured w ...[more]

PMID: 27314234

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Project description:IntroductionPrimary open-angle glaucoma is estimated to affect 3% of the population aged 40-80 years. Trabeculectomy is considered the gold standard in surgical management of glaucoma; however, it is a technically complex procedure that may result in a range of adverse outcomes. Device-augmented, minimally invasive procedures (micro-invasive glaucoma surgeries, MIGS) have been developed aiming for safer and less invasive intraocular pressure (IOP) reduction compared with traditional surgery.MethodsThis paper presents results from a systematic literature review conducted in accordance with National Institute for Health and Care Excellence requirements for the Medical Technology Evaluation Programme via multiple databases from 2005 to 2016. For clinical outcomes, randomized clinical trials (RCTs) comparing MIGS with trabeculectomy or other therapies, observational studies, and other non-RCTs were included. Clinical outcomes reviewed were the change from baseline in mean IOP levels and change in topical glaucoma medication. Safety was assessed by reported harm and adverse events. For economic evidence, trials on cost-effectiveness, cost-utility, cost-benefit, cost-consequences, cost-minimization, cost of illness, and specific procedure costs were included. Risk of bias was assessed for clinical studies using the Cochrane Risk of Bias tool.ResultsA total of nine RCTs (seven iStents®, one Hydrus®, and one CyPass®), seven non-RCTs (three iStent®, three CyPass®, and one Hydrus®), and 23 economic studies were analyzed. While various forms of trabeculectomy can achieve postoperative IOP of between 11.0 and 13.0 mmHg, MIGS devices described in this review were typically associated with higher postoperative IOP levels. In addition, MIGS devices may result in increased hypotony rates or bleb needling in subconjunctival placed devices, requiring additional medical resources to manage. There is limited available evidence on the cost-effectiveness of MIGS and therefore it remains unclear whether the cost of using MIGS is outweighed by cost savings through decreased medication and need for further interventions.ConclusionLarger randomized trials and real-world observational studies are needed for MIGS devices to better assess clinical and economic effectiveness. Given the shortage of published data and increasing use of such procedures, living systematic reviews may help to provide ongoing and timely evidence-based direction for clinicians and decision makers. This review highlights the current unmet need for treatments that are easy to implement and reduce long-term IOP levels without increasing postoperative aftercare and cost.FundingSanten GmbH, Germany.

Project description:PurposeThe outer stent lumen can be located either deeper (in or under Tenon's layer) or more superficially in the conjunctival stroma after the transscleral XEN Glaucoma Gel Microstent (XEN-GGM; Allergan Plc., USA) implantation. The present study aimed to investigate the effect of the postoperative conjunctival implant position on surgical success and intraocular pressure (IOP) after XEN-GGM.MethodsProspective data from 66 consecutive open-angle glaucoma eyes of 54 patients were collected preoperatively and 1 and 2 weeks, and 1, 6 and 12 months postoperatively. The layer of implantation was determined in the first month postoperatively as intra- and subtenon or intraconjunctival depending on the location of the outer lumen of the stent in OCT (Visante OCT; Zeiss, Germany). Primary outcome measures were differences in relative IOP reduction at 12 months between the two groups. Further, complete and qualified surgical success, number of secondary needlings and number of IOP-lowering medications and absolute IOP were assessed.ResultsRelative IOP reduction was higher in intra- and subtenon group (n = 37/66, 56%) at week 1 (-54% versus -19%, p < 0.001), week 2 (-39% versus -21%, p = 0.02), month 1 (-42% versus -28%, p = 0.035) and month 12 (-39% versus -24%, p = 0.024). The mean absolute IOP was lower in intra- and subtenon group at week 1 (10.8 [95%CI, 8.8-14.1] versus 16.6 [95%CI, 14.1-19.0] mmHg, p < 0.001) and months 12 (13.9 [95%CI, 12.4-15.4] versus 16.7 [95%CI, 14.6-18.8] mmHg, p = 0.041). At month 6, a lower burden for IOP-lowering medication was shown for the intra- and subtenon group (0.2 ± 0.5 versus 1.0 ± 1.1, p = 0.034). The mean number of secondary needlings, which were done in 47/66 (71%) of the eyes, was lower in the intra- and subtenon group in the first year (1.9 ± 1.7 versus 1.2 ± 1.2, p = 0.03). Qualified surgical success was higher in the intra- and subtenon group (90% versus 61%, p = 0.01) after 1 year.ConclusionThe present study demonstrates a higher efficacy achieved with lower secondary needling rates in deeper implant positions in conjunctiva after XEN-GGM.

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The New Era of Glaucoma Micro-stent Surgery.

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The New Era of Glaucoma Micro-stent Surgery.

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