Swedish Microinvasive Glaucoma Surgery Study (SMIGS)

Sponsor
Umeå University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05035394
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
71.5
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Cataract surgery
  • Procedure: KDB
  • Procedure: Istent
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Sep 16, 2021
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Cataract

Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion.

Procedure: Cataract surgery
Cataract Surgery in a standardized fashion
Other Names:
  • Phacoemulsification
  • Cataract Surgery as stand-alone
  • Active Comparator: 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.

    Procedure: KDB
    Goniotomy with KDB glide will be performed at the end of Cataract Surgery
    Other Names:
  • Kahook Dual Blade Glide, New World Medical, Inc, Rancho Cucamonga, CA
  • KDB glide
  • Active Comparator: 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.

    Procedure: Istent
    Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery
    Other Names:
  • iStent inject W
  • Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, California
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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)

    Secondary Outcome Measures

    1. 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)

    Other Outcome Measures

    1. Number of participants that need further surgery [12 to 24 months]

      Arm comparison of future need for microinvasive surgery, filtering surgery or cyclodestructive laser

    2. Number of participants that need additional medical therapy [12 to 24 months]

      Assessment of the need for future medical therapy in the study groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Eye clinic at the hospital of OstersundOstersundÖstersundSweden83183

    Sponsors and Collaborators

    • Umeå University

    Investigators

    • Principal Investigator: Anna Barkander, MD, Hospital of Ostersund, department of Ophtalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Barkander, Principal Investigator, Umeå University
    ClinicalTrials.gov Identifier:
    NCT05035394
    Other Study ID Numbers:
    • 2021-02970
    First Posted:
    Sep 5, 2021
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 28, 2021