Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

Not Applicable

Active, not recruiting

• Conditions: Open Angle Glaucoma; MIGS; Istent Inject W; Cataract; Kahook Dual Blade Glide; Goniotomy
• Interventions: Procedure: KDB; Procedure: Cataract surgery; Procedure: Istent

• Registration Number: NCT05035394
• Lead Sponsor: Umeå University

Brief 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).

Study Timeline

• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-05
• Study Start: 2021-09-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Only one eye per participant
• Clinically significant cataract
• Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
• Open chamber angle with Schaffer grading three to four in at least two quadrants

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Exclusion Criteria

• Previous glaucoma surgery, including cyclodestructive procedures.
• Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
• Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
• Unable to participate and make written consent due to another medical condition.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cataract surgery in combination with Kahook Dual Blade glide goniotomy	KDB	Cataract surgery combined with Kahook Dual Blade Glide goniotomy. The goniotomy will be performed at the end of cataract surgery through the temporal cataract incision.
Cataract surgery as stand alone	Cataract surgery	Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion.
Cataract surgery in combination with iStent Inject W implantation	Istent	Cataract surgery combined with iStent Inject W. The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.

Primary Outcome Measures

Name	Time	Method
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline	12 to 24 months	Intraocular pressure measured by Goldmann applanation tonometry (GAT)
Change in the number of intraocular pressure lowering medications compared to baseline	12 to 24 months	Accountability of intraocular pressure lowering medications used by the patient

Secondary Outcome Measures

Name	Time	Method
Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg	12 to 24 months	Intraocular pressure measured by Goldmann applanation tonometry (GAT)

Trial Locations

Locations (1)

Eye clinic at the hospital of Ostersund; 🇸🇪 Ostersund, Östersund, Sweden