Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Exfoliation Glaucoma, Cataract

Intervention / Treatment
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* Procedure: iStent
* Procedure: SLT-laser
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stable glaucoma iStent<br>Cataract surgery combined with iStent inject | Procedure: iStent<br>* 2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork<br>* Other names: Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California;Procedure: Cataract surgery<br>* Conventional cataract surgery<br>|
| Experimental: Stable glaucoma SLT-laser<br>Cataract surgery combined with SLT-laser 1 month after surgery | Procedure: SLT-laser<br>* 1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)<br>* Other names: Selective laser trabeculoplasty;Procedure: Cataract surgery<br>* Conventional cataract surgery<br>|
| Active Comparator: Stable glaucoma<br>Cataract surgery | Procedure: Cataract surgery<br>* Conventional cataract surgery<br>|
| Experimental: Unstable glaucoma iStent<br>Cataract surgery combined with iStent inject | Procedure: iStent<br>* 2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork<br>* Other names: Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California;Procedure: Cataract surgery<br>* Conventional cataract surgery<br>|
| Experimental: Unstable glaucoma SLT-laser<br>Cataract surgery combined with SLT-laser 1 month after surgery | Procedure: SLT-laser<br>* 1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)<br>* Other names: Selective laser trabeculoplasty;Procedure: Cataract surgery<br>* Conventional cataract surgery<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLT, iStent