NCT05035394

Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

A Prospective Randomized Trial Comparing Cataract Surgery as Stand Alone and Cataract Surgery Combined With Kahook Dual Blade Glide Goniotomy or Istent Inject W Trabecular Micro-Bypass Stent in Open-Angle Glaucoma.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to 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 as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).

Conditions

• Open Angle Glaucoma
• Cataract
• Kahook Dual Blade Glide
• Istent Inject W
• MIGS
• Goniotomy

Interventions

Type	Name	Description
PROCEDURE	Cataract surgery	Cataract Surgery in a standardized fashion
PROCEDURE	KDB	Goniotomy with KDB glide will be performed at the end of Cataract Surgery
PROCEDURE	Istent	Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery

Timeline

• Start date: 2021-09-16
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2021-09-05
• Last updated: 2025-06-05

Locations

1 site across 1 country: Sweden