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COILEH: Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04635020
Collaborator
(none)
285
Enrollment
1
Location
5
Arms
155
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)

Condition or Disease Intervention/Treatment Phase
  • Procedure: iStent
  • Procedure: SLT-laser
  • Procedure: Cataract surgery
 N/A

Detailed Description

Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
285 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stable glaucoma iStent

Cataract surgery combined with iStent inject

Procedure: iStent
2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
Other Names:
  • Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California

    • Procedure: Cataract surgery
    Conventional cataract surgery
    Experimental: Stable glaucoma SLT-laser

    Cataract surgery combined with SLT-laser 1 month after surgery

    Procedure: SLT-laser
    1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
    Other Names:
  • Selective laser trabeculoplasty

    • Procedure: Cataract surgery
    Conventional cataract surgery
    Active Comparator: Stable glaucoma

    Cataract surgery

    Procedure: Cataract surgery
    Conventional cataract surgery
    Experimental: Unstable glaucoma iStent

    Cataract surgery combined with iStent inject

    Procedure: iStent
    2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
    Other Names:
  • Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California

    • Procedure: Cataract surgery
    Conventional cataract surgery
    Experimental: Unstable glaucoma SLT-laser

    Cataract surgery combined with SLT-laser 1 month after surgery

    Procedure: SLT-laser
    1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
    Other Names:
  • Selective laser trabeculoplasty

    • Procedure: Cataract surgery
    Conventional cataract surgery

    Outcome Measures

    Primary Outcome Measures

    1. Group I: Change in the number of IOP lowering medications compared to baseline [12 months]

      Accountability of IOP lowering medications used by the patient

    2. Group II: Change in the IOP compared to baseline [12 months]

      IOP measured by Goldmann aplanation tonometry (GAT)

    Secondary Outcome Measures

    1. Group I: Change in the IOP compared to baseline [12 months]

      IOP measured by GAT

    2. Group II: Change in the number of IOP lowering medications compared to baseline [12 months]

      Accountability of IOP lowering medications used by the patient

    Other Outcome Measures

    1. Group I and II: Number of patients with secondary glaucoma surgery [10 years]

      Number of patients with secondary glaucoma surgery at 10 years from baseline is counted

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed consent of information

    • Clinical significant cataract

    • Able to attend 12 month period

    • Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS)

    • Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication

    • Target IOP ≥16

    • Able to understand Finnish, Swedish or English

    Exclusion Criteria:

    • Clinical set target IOP < 16 mmHg in advanced glaucoma

    • Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications

    • Closed angle

    • Congenital angle anomaly

    • Clinically significant corneal dystrophy or other hindering corneal condition

    • Unable to use topical medical therapy

    • Central corneal thickness of less than 480um or more than 620um

    • Active uveitis, cystic macular edema (CME), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis.

    • Previous intraocular surgery, refractive surgery or cycloablation

    • Two or more prior SLT or laser trabeculoplasty

    • Unable to participate due to another medical disease or condition

    • Participating in another clinical trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Helsinki University Hospital Helsinki Finland

    Sponsors and Collaborators

    • Helsinki University Central Hospital

    Investigators

    • Principal Investigator: Mika Harju, MD, prof., Helsinki University Central Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Mika Harju, MD, professor, Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT04635020
    Other Study ID Numbers:
    • 123123
    First Posted:
    Nov 18, 2020
    Last Update Posted:
    Nov 18, 2020
    Last Verified:
    Nov 1, 2020
    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
    Keywords provided by Prof. Mika Harju, MD, professor, Helsinki University Central Hospital
    SLT
    iStent
    Additional relevant MeSH terms:
    Glaucoma
    Cataract
    Exfoliation Syndrome

    Study Results

    No Results Posted as of Nov 18, 2020