Investigation of the iStent Inject® Devices in Open-Angle Glaucoma

Study Overview
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Brief Summary
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The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.

Detailed Description
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Patients suffering from open-angle glaucoma who are planning to undergo cataract surgery and are matching the inclusion criteria will be offered to join the study until the desired sample size (50) is reached. Combined cataract-iStent surgery will be performed as per the devices' manufacturers' instructions. Two iStent inject devices will be micro-invasively implanted in the trabecular meshwork of the eye during planned cataract surgery. Six post-operative follow-ups will be carried out over a duration of 12 months, during which various measurements will be made. Performance Outcomes will analyse the proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 6 and 12 months. Quality of life outcome will look at the improvement in perceived quality of life as expressed in the NEI VFQ-25 questionnaires from baseline to 3 and 12 months. The rate of adverse events will be recorded.

Official Title
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A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Device: Glaukos iStent inject®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma Mild to moderate glaucoma (defined as C/D ratio ≤ 0.8) Phakic eye requiring cataract surgery Preoperative IOP up to 30 mmHg (medicated or not) Patients with side-effects to, or complications from, medications Patients who would benefit from a reduction of IOP and/or reduction of medication Normal angle anatomy as determined by gonioscopy; Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair proper placement of iStent inject device Able and willing to attend scheduled follow-up exams for 12 months postoperatively Able and willing to provide written informed consent on the approved Informed Consent Form Exclusion Criteria: Inclusion of the fellow eye in this study (only one eye per subject) Aphakic patients or pseudophakic patients Prior stent implantations in the study eye Eyes with primary angle closure glaucoma, or any secondary angle closure glaucoma Traumatic or uveitic glaucoma; or any glaucoma associated with vascular disorders Patients with any type of condition that may cause elevated episcleral venous pressure Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma Prior glaucoma treatment (laser or surgery) Any active corneal inflammation, edema, or opacity severe-enough to impair gonioscopy / fundus examination Any pathology for which, in the investigator's judgment, the following would be either at risk or contraindicated: stent implantation, compliance to elements of the study protocol.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: Historic control (before vs. after intervention).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaukos iStent inject®<br>Patients suffering from cataract and open-angle glaucoma. Glaukos iStent inject® is implanted during routine cataract surgery. The effect on IOP/glaucoma medications is monitored. | Device: Glaukos iStent inject®<br>* iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Outcome: IOP reduction | Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: NEI VFQ-25 score | Improvement in perceived quality of life as expressed in the NEI VFQ-25 (National Eye Institute Vision Function) questionnaires from baseline to 12 months. | 12 months | 
| Safety Outcome: Adverse events | Rate of adverse events through the follow-up period. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, Minimally Invasive Glaucoma Surgery