Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Detailed Description
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The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Official Title
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A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: iStent
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate primary open-angle glaucoma currently treated with ocular hypotensive medication pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses subject scheduled to undergo cataract surgery Exclusion Criteria: primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

Ages Eligible for Study
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Minimum Age: 22 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iStent<br>Implantation of one iStent in conjunction with cataract surgery | Device: iStent<br>* Implantation of one iStent in conjunction with cataract surgery<br>* Other names: GTS100;|
| Active Comparator: Cataract surgery<br>Cataract surgery alone | Procedure: Cataract surgery<br>* Cataract surgery alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sight-threatening adverse events |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other adverse events | For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iStent, Primary open-angle glaucoma (POAG), Trabecular meshwork