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

A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma

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)

Study Overview

• Status: Recruiting
• Conditions: Cataract; Exfoliation Glaucoma
• Intervention / Treatment: Procedure: iStent; Procedure: Cataract surgery; Procedure: SLT-laser

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 Type: Interventional
• Enrollment (Anticipated): 285
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eeva Ojanen, MD; Phone Number: +358503608589; Email: eeva.ojanen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Hospital
    • Contact: Eeva Ojanen, MD; Phone Number: +358 503608589; Email: eeva.ojanen@hus.fi
    • Principal Investigator: Mika Harju, MD prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / 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: Cataract surgery; Conventional cataract surgery; Procedure: SLT-laser; 1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees); Other Names: Selective laser trabeculoplasty
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: Cataract surgery; Conventional cataract surgery; Procedure: SLT-laser; 1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees); Other Names: Selective laser trabeculoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group I: Change in the number of IOP lowering medications compared to baseline	Accountability of IOP lowering medications used by the patient	12 months
Group II: Change in the IOP compared to baseline	IOP measured by Goldmann aplanation tonometry (GAT)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group I: Change in the IOP compared to baseline	IOP measured by GAT	12 months
Group II: Change in the number of IOP lowering medications compared to baseline	Accountability of IOP lowering medications used by the patient	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group I and II: Number of patients with secondary glaucoma surgery	Number of patients with secondary glaucoma surgery at 10 years from baseline is counted	10 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2033

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: iStent; SLT
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Uveal Diseases; Lens Diseases; Iris Diseases; Glaucoma; Cataract; Exfoliation Syndrome
• Other Study ID Numbers: 123123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No