Minimally Invasive Glaucoma Surgery: Safety of Individual Devices

Abstract

Primary open-angle glaucoma progression in those already on maximal medical therapy has traditionally been treated with trabeculectomy, a surgical procedure that carries a high degree of morbidity. In the last few decades, significant advances have been made in the field of minimally invasive glaucoma surgery (MIGS) devices, which aim to defer or prevent trabeculectomy via less arduous surgical techniques in certain types of glaucoma. Although reviews have been published examining the efficacy of various MIGS techniques, no article synthesises the comparative safety of all available devices. We performed a literature review examining the safety of MIGS devices. Fifteen devices were included, variously attempting to increase aqueous outflow through the trabecular meshwork or the suprachoroidal space, shunting into the subconjunctival space, or reducing aqueous production through ciliary body ablation. Notably, the earliest product attempting to increase outflow to the suprachoroidal space, Alcon’s CyPass Micro-Stent, was withdrawn from the market due to concerns regarding increased corneal endothelial cell loss at five years post-implantation. All other devices were described as well-tolerated, with the most common adverse effects including hyphaema, intraocular pressure spikes, and device migration or obstruction. MIGS devices are purported to be uniformly safe, and many studies report no statistically significant increased complications beyond those associated with cataract surgery alone. It is important to note, however, the generally poor quality of current studies, with a dearth of randomised, or even prospective, data, and a large proportion of studies funded by device producers.

Minimally Invasive Glaucoma Surgery

“…97,[99][100][101] The type of approach (ie, viscodilation only vs. viscodilation and trabeculotomy) and whether concurrent cataract extraction is performed can significantly influence the occurrence and nature of complications that may arise during or after the procedure. 102 ' Non-bleb Forming, Suprachoroidal Space Approaches Ab interno MIGS devices designed to target the suprachoroidal space include the iStent Supra G3 (Glaukos Inc., Laguna Hills, CA) and the MINIject (iStar Medical, Wavre, Belgium). Neither has received FDA approval as of June 2023.…”

“…Other adverse events included posterior capsule opacification in 10.4% of cases, cystoid macular edema in 6.3% of cases, and corneal edema in 4.2% of cases 97,99–101 . The type of approach (ie, viscodilation only vs. viscodilation and trabeculotomy) and whether concurrent cataract extraction is performed can significantly influence the occurrence and nature of complications that may arise during or after the procedure 102 …”

„Minimally invasive glaucoma surgery“ – Kammerwinkelbasierte Verfahren im Vergleich

“…Vermutlich ausgelöst durch mechanische Irritationen, kommt es zu Reizzuständen, die durch die Entfernung der Stents beruhigt werden können. Weiterhin wurden Stentokklusionen und IOD-Spitzen als postoperative Komplikationen beschrieben [21].…”

“…Die beschriebenen Komplikationen sind vergleichbar mit denen des iStent (IOD-Spitzen, Hyphäma, Stentokklusion) und in den wenigsten Fällen schwerwiegend [21].…”

“…Weiterhin zeigten sich Druckspitzen (0-22,2 %) und/oder ein Hornhautödem (0-6,2 %). Sehr seltene KomplikationenwarenfibrinöseUveitiden, eine Iridodialyse oder ein Iristrauma, Hypotonien, Descemetolyse, zystoides Makulaödem, Visusverschlechterung und Aderhautabhebungen [21].…”