GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Detailed Description
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Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.

Official Title
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A Prospective, Randomized, Controlled, Parallel Groupos, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery

Conditions
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Glaucoma

Intervention / Treatment
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* Device: iStent Inject (GTS400)
* Procedure: Cataract Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with open-angle glaucoma in the study eye Subject must be on 1 to 3 glaucoma medications Subject able and willing to attend follow up visits for two years postop Subject able and willing to sign informed consent Exclusion Criteria: Pseudoexfoliative and pigmentary glaucoma Prior glaucoma surgery of any type

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: Cataract Surgery Only<br> | Procedure: Cataract Surgery<br>* Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.<br>|
| Experimental: Treatment with Cataract Surgery & Stents<br>Ab interno trabecular micro-bypass stent surgery | Device: iStent Inject (GTS400)<br>* Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.<br>* Other names: Cataract surgery, stent implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open angle, Glaucoma, Cataract, Surgery, Intraocular Pressure