Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

Last updated: June 2, 2025
Sponsor: Umeå University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

Cataract surgery

Istent

KDB

Clinical Study ID

NCT05035394
2021-02970
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Only one eye per participant

  • Clinically significant cataract

  • Glaucoma or intraocular hypertension treated with one to four medications and noneed 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

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 intraoculareye pressure or visual field.

  • Unable to participate and make written consent due to another medical condition.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Cataract surgery
Phase:
Study Start date:
September 16, 2021
Estimated Completion Date:
September 30, 2027

Study 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).

Connect with a study center

  • Eye clinic at the hospital of Ostersund

    Ostersund, Östersund 83183
    Sweden

    Site Not Available

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