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Clinical Trials in Sweden / NCT05035394
Active, not recruiting Not applicable

Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

NCT05035394 · tracked via the Priya Life Science Sweden tracker
Sponsor
Umeå University
Phase
Not applicable
Started
2021-09-16
Last updated
2025-06-05

Condition(s) studied

Open Angle GlaucomaCataractKahook Dual Blade GlideIstent Inject WMIGSGoniotomy

Investigational drug(s) / intervention(s)

Cataract surgeryKDBIstent

Cataract surgery: Cataract Surgery in a standardized fashion

KDB: Goniotomy with KDB glide will be performed at the end of Cataract Surgery

Istent: Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 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.

Primary outcome measure(s)

  • 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
  • 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)

Trial sites (1)

FacilityCityRegionStatus
Eye clinic at the hospital of Ostersund Östersund Östersund

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05035394 on ClinicalTrials.gov ↗ ← All trials in Sweden