Translating Minimally Invasive Glaucoma Surgery Devices.

Richard M.H Lee,Peng Tee Khaw,Ian Eames,Yann Bouremel,Steve Brocchini

doi:10.1111/cts.12660

Abstract

Glaucoma is the leading cause of irreversible blindness with over 70 million people affected worldwide. The surgical management of glaucoma aims to lower intraocular pressure by increasing aqueous outflow facility. The latest manufacturing techniques have allowed for the development of a number of novel implantable devices to improve safety and outcomes of glaucoma surgery. These are collectively referred to as minimally invasive glaucoma surgery (MIGS) devices and are among the smallest devices implanted in the human body. This review discusses the design criterion and constraints as well as the user requirements for MIGS devices. We review how recent devices have attempted to meet these challenges and give our opinion as to the necessary characteristics for the development of future devices.

Highlights

Glaucoma is the leading cause of irreversible blindness with over 70 million people affected worldwide
Intraocular pressure (IOP) is the only risk factor that can be modified in the treatment of glaucoma to reduce disease progression
Several multicenter clinical trials have shown the value of lowering intraocular pressure (IOP) to within normal limits (11–21 mmHg) in patients with ocular hypertension or primary open-angle glaucoma1 to prevent disease progression

Summary

Introduction

Glaucoma is the leading cause of irreversible blindness with over 70 million people affected worldwide. Medical or laser therapy does not lower IOP enough to reduce disease progression or they are unable to tolerate the side effects associated with these treatments In these patients, the surgical routes involve glaucoma filtration surgery (GFS; Figure 1) or the implantation of a glaucoma drainage device (GDD). There is a clinical need for better designed devices with improved flow control and biocompatibility while being safe and easy to insert to improve uptake among general ophthalmologists, not just those who have undergone further subspecialty training in glaucoma To meet this clinical need, a number of devices have recently been developed labeled as either micro-incision or minimally invasive glaucoma surgery (MIGS) devices that modulate aqueous humor outflow facility via one of several routes (Figure 2). The US Food and Drug Administration (FDA) recently published their premarket approval guidance for MIGS devices in 2015 to outline their recommendations for studies that MIGS device manufacturers should perform to streamline the process for bringing these devices to market. The FDA defined MIGS devices in their recent guidance as “a type of IOP lowering device used to lower IOP using an outflow mechanism with either an ab interno or ab externo approach, associated with little or no scleral dissection and minimal or no conjunctival manipulation.”

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