Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

Study Overview
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Brief Summary
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Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Detailed Description
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Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Official Title
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A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin

Conditions
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Open-Angle Glaucoma

Intervention / Treatment
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* Device: iStent and iStent supra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs) Open-angle glaucoma (including pseudoexfoliative) Exclusion Criteria: Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs) Prior ALT Prior SLT within 90 days of screening visit

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: iStent and iStent supra<br>Implantation of two iStent devices and one iStent supra device | Device: iStent and iStent supra<br>* Implantation of two iStent devices and one iStent supra device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP | Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal IOP < 18mm Hg | Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 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, Prior trabeculectomy