Randomised controlled trial on the efficacy of Kahook dual blade goniotomy assisted MIGS versus I- stent implantation in patients with open angle glaucoma in Indian population

Open Angle Glaucoma, a chronic and progressive optic neuropathy, is characterised by damage

to the optic nerve, leading to visual field loss and cupping of the optic disc. It represents the

second leading cause of irreversible blindness globally. The economic and social impact of

managing glaucoma is significant in both developed and developing nations, contributing to 8%

of worldwide blindness.Intra-ocular pressure (IOP) is a key modifiable risk factor and the

primary target for treatment.Topical medications have a proven record of efficacy and are

used as first-line therapy at all stages of glaucoma and ocular hypertension. Though chronic

medication use is generally safe, efficacy is frequently undermined by high rates of patient

noncompliance which increase when multiple medications are concurrently prescribed.Medications are also associated with side effects and may exacerbate dry eye and ocular

surface disease.Consequently, researchers have continually sought innovative surgical

approaches for glaucoma that can reduce IOP while maintaining a favourable safety profile.

These newer procedures often utilise an ab- interno approach, minimising tissue trauma and

promoting faster recovery.This category of procedures is generally referred to as micro

invasive or minimally invasive glaucoma surgery (MIGS). MIGS has become a less invasive

option compared to traditional glaucoma surgeries, offering the potential for effective IOP

reduction with enhanced safety. Two commonly performed MIGS procedures are goniotomy

using the Kahook Dual Blade (KDB) and implantation of the I-Stent. KDB goniotomy involves

removing the compromised trabecular meshwork to improve aqueous humor outflow, whereas

the i-Stent procedure involves placing tiny stents within Schlemm’s canal to bypass the

trabecular meshwork. While both KDB goniotomy and i-Stent implantation have been shown

to be effective in lowering IOP, there is a lack of head-to-head comparative data, particularly

regarding long-term results. This randomized controlled trial (RCT) is designed to directly

compare the effectiveness of KDB goniotomy-assisted MIGS and iStent implantation in reducing

IOP in Indian patients with open-angle glaucoma. The findings of this study will contribute

valuable data to inform clinical practice and improve treatment strategies for this condition