Estudio comparativo de facoemulsificación de catarata más trabeculotomía ab interno (Kahook Dual Blade) vs facoemulsificación de catarata para el control de la presión intraocular

Abstract

Glaucoma is one of the leading causes of irreversible blindness worldwide. Although the exact prevalence is difficult to determine, glaucoma is estimated to affect about 1.1-2.3% of the world’s population. Although several risk factors can predispose to develop glaucoma, it is the increased intraocular pressure (IOP) the only modifiable that can slow disease progression. In normal functioning, aqueous humor outflows in two different ways, the suprachoroidal pathway and the conventional pathway. To date, the conventional pathway, involving the trabecular meshwork, Schlemm’s canal, collector channels and aqueous veins, is the main responsible of the elevated IOP, due to an increased resistance and stiffness in normal drainage of the aqueous humor. Surgical treatment is considered when glaucoma eyedrops or laser treatments do not achieve a significant reduction in IOP, glaucoma eyedrops are no longer tolerated or the disease is diagnosed at a such an end-stage phase that any other options would lead to a complete loss of the visual field. In those scenarios, filtering surgeries and glaucoma drainage devices remain the preferred treatment options due to their efficacy in reducing IOP and the limited amount of glaucoma medications needed after surgery. Although they are the surgical refence in glaucoma surgery and several safety mechanisms have been developed, potential sight-threatening complications from these procedures have led into new surgical options. Over the last decade, there has been an increasing interest in micro-invasive glaucoma surgeries (MIGS). MIGS are defined as a surgical option that would result in minimal trauma to the target tissue, had at least modest efficacy, a high safety profile and rapid recovery after surgery. MIGS are further classified according to the anatomical or functional pathway they approach. Those MIGS that act on the trabecular meshwork are both theoretically and practically appealing due to two main reasons: they usually require minimal intraocular manipulation, and can either bypass or remove the trabecular meshwork. The Kahook Dual Blade® (KDB; New World Medical, Rancho Cucamonga, CA, USA) is a novel, single-use dual blade specially designed to almost completely eliminate the TM with a single cut. Preclinical investigation has demonstrated that the dual blade allows both removal of the TM and increased aqueous outflow with a gentle effect on surroundings tissues. In real-life practice, ab interno trabeculectomy with the KDB combined with cataract surgery has achieved a significant mid-term reduction in IOP. OBJECTIVES: To determine the efficacy and safety of the ab interno trabeculectomy with KDB combined with standard cataract surgery. Primary objective: to evaluate the reduction in intraocular pressure and number of glaucoma medications achieved with ab interno trabeculectomy with Kahook Dual Blade, combined with standard cataract surgery. To compare this reduction with the cut-off achieved with standard cataract surgery alone...