Systematic Literature Review of Clinical and Economic Outcomes of Micro-Invasive Glaucoma Surgery (MIGS) in Primary Open-Angle Glaucoma

Abstract

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.Electronic supplementary materialThe online version of this article (10.1007/s40123-018-0131-0) contains supplementary material, which is available to authorized users.

Open-Angle Glaucoma: Burden of Illness, Current Therapies, and the Management of Nocturnal IOP Variation

“…MIGS procedures carry a superior safety profile compared with traditional surgery but are less effective at lowering IOP and reducing medication burden [47][48][49]. In addition, while MIGS offer a safer alternative to surgery for patients with mild-to-moderate disease who are intolerant to pharmacotherapy, such procedures still have attendant risks of adverse events such as infection and hypotony, often necessitating additional device-related interventions or surgery [50,51]. Studies also demonstrate that MIGS procedures are more effective in patients with higher baseline IOP.…”

Numerical model to predict and compare the hypotensive efficacy and safety of minimally invasive glaucoma surgery devices

“…Recently, several new surgery implants, known as Minimally-Invasive Glaucoma Surgery (MIGS) have been developed to improve the efficacy and safety of conventional glaucoma surgery [5]. These implants work by increasing filtration of AH, either through its natural route (iStent implant), or by rerouting the AH flow into either the subconjunctival space (XEN implants and PreserFlo microshunt) or the suprachoroid space (CyPass Micro-Stent implant) [6].…”

<p>Prospective Studies of Minimally Invasive Glaucoma Surgeries: Systematic Review and Quality Assessment</p>

“…They concluded that MIGS studies showed reduction of IOP, reduction of glaucoma medication, and a good safety profile, but much of these data came from comparative case studies, identifying a need for more RCTs of MIGS. Similarly, in the systemic review by Agrawal and Bradshaw, 5 nine RCTs were included and some MIGS procedures/devices were found to have no RCTs. They suggested that more "real world studies" and economic studies are needed to evaluate MIGS.…”