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

Primary Purpose

Exfoliation Glaucoma, Cataract

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
iStent
SLT-laser
Cataract surgery
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exfoliation Glaucoma focused on measuring SLT, iStent

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Stable glaucoma iStent

Stable glaucoma SLT-laser

Stable glaucoma

Unstable glaucoma iStent

Unstable glaucoma SLT-laser

Arm Description

Cataract surgery combined with iStent inject

Cataract surgery combined with SLT-laser 1 month after surgery

Cataract surgery

Cataract surgery combined with iStent inject

Cataract surgery combined with SLT-laser 1 month after surgery

Outcomes

Primary Outcome Measures

Group I: Change in the number of IOP lowering medications compared to baseline
Accountability of IOP lowering medications used by the patient
Group II: Change in the IOP compared to baseline
IOP measured by Goldmann aplanation tonometry (GAT)

Secondary Outcome Measures

Group I: Change in the IOP compared to baseline
IOP measured by GAT
Group II: Change in the number of IOP lowering medications compared to baseline
Accountability of IOP lowering medications used by the patient

Full Information

First Posted
October 29, 2020
Last Updated
November 17, 2020
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04635020
Brief Title
Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group
Acronym
COILEH
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exfoliation Glaucoma, Cataract
Keywords
SLT, iStent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stable glaucoma iStent
Arm Type
Experimental
Arm Description
Cataract surgery combined with iStent inject
Arm Title
Stable glaucoma SLT-laser
Arm Type
Experimental
Arm Description
Cataract surgery combined with SLT-laser 1 month after surgery
Arm Title
Stable glaucoma
Arm Type
Active Comparator
Arm Description
Cataract surgery
Arm Title
Unstable glaucoma iStent
Arm Type
Experimental
Arm Description
Cataract surgery combined with iStent inject
Arm Title
Unstable glaucoma SLT-laser
Arm Type
Experimental
Arm Description
Cataract surgery combined with SLT-laser 1 month after surgery
Intervention Type
Procedure
Intervention Name(s)
iStent
Other Intervention Name(s)
Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California
Intervention Description
2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
Intervention Type
Procedure
Intervention Name(s)
SLT-laser
Other Intervention Name(s)
Selective laser trabeculoplasty
Intervention Description
1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Conventional cataract surgery
Primary Outcome Measure Information:
Title
Group I: Change in the number of IOP lowering medications compared to baseline
Description
Accountability of IOP lowering medications used by the patient
Time Frame
12 months
Title
Group II: Change in the IOP compared to baseline
Description
IOP measured by Goldmann aplanation tonometry (GAT)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Group I: Change in the IOP compared to baseline
Description
IOP measured by GAT
Time Frame
12 months
Title
Group II: Change in the number of IOP lowering medications compared to baseline
Description
Accountability of IOP lowering medications used by the patient
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Group I and II: Number of patients with secondary glaucoma surgery
Description
Number of patients with secondary glaucoma surgery at 10 years from baseline is counted
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eeva Ojanen, MD
Phone
+358503608589
Email
eeva.ojanen@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika Harju, MD, prof.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eeva Ojanen, MD
Phone
+358 503608589
Email
eeva.ojanen@hus.fi
First Name & Middle Initial & Last Name & Degree
Mika Harju, MD prof

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

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