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

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ClinicalTrials.gov Identifier: NCT04635020
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Mika Harju, Helsinki University Central Hospital

Study Description
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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
Exfoliation Glaucoma Cataract Procedure: iStent Procedure: SLT-laser Procedure: Cataract surgery Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Selective laser trabeculoplasty

Procedure: Cataract surgery
Conventional cataract surgery


Outcome Measures
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Primary Outcome Measures :
  1. Group I: Change in the number of IOP lowering medications compared to baseline [ Time Frame: 12 months ]
    Accountability of IOP lowering medications used by the patient

  2. Group II: Change in the IOP compared to baseline [ Time Frame: 12 months ]
    IOP measured by Goldmann aplanation tonometry (GAT)


Secondary Outcome Measures :
  1. Group I: Change in the IOP compared to baseline [ Time Frame: 12 months ]
    IOP measured by GAT

  2. Group II: Change in the number of IOP lowering medications compared to baseline [ Time Frame: 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 [ Time Frame: 10 years ]
    Number of patients with secondary glaucoma surgery at 10 years from baseline is counted


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635020


Contacts
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Contact: Eeva Ojanen, MD +358503608589 eeva.ojanen@hus.fi

Locations
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Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Eeva Ojanen, MD    +358 503608589    eeva.ojanen@hus.fi   
Principal Investigator: Mika Harju, MD prof         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Mika Harju, MD, prof. Helsinki University Central Hospital
More Information
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Responsible Party: Prof. Mika Harju, MD, professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04635020    
Other Study ID Numbers: 123123
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Mika Harju, Helsinki University Central Hospital:
SLT
iStent
Additional relevant MeSH terms:
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Glaucoma
Cataract
Exfoliation Syndrome
Ocular Hypertension
 Eye Diseases
Lens Diseases
Iris Diseases
Uveal Diseases