NCT07325552

iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical University of Bialystok · Academic / Other
• Sex: All
• Age: 18 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the efficacy of cataract surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.

Detailed description

Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery combined with Kahook Dual Blade Glide (50 patients) or iStent Inject W (50 patients).

Conditions

• Open Angle Glaucoma (OAG)

Interventions

Type	Name	Description
DEVICE	Goniotomy with KDB blade goniotomy	Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision.
DEVICE	Two iStent inject implanation	The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

2 sites across 1 country: Poland

Regulatory

• FDA-regulated device study