A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent

Overview

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Full Title of Study: “A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 16, 2019

Detailed Description

The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Interventions

  • Device: iStent Supra Stent
    • Implantation of one iStent Supra Stent through a small temporal clear corneal incision

Arms, Groups and Cohorts

  • Experimental: One iStent Supra Stent and medication
    • The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma

Clinical Trial Outcome Measures

Primary Measures

  • Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
    • Time Frame: 12 months

Secondary Measures

  • Mean diurnal Intraocular Pressure < 18 mmHg at month 12
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosed with primary open-angle glaucoma (POAG) – Subjects on two topical hypotensive medications Exclusion Criteria:

  • Traumatic, uveitic, neovascular, or angle closure glaucoma – Fellow eye already enrolled

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Glaukos Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lilit Voskanyan, MD, Principal Investigator, SV Malayan Ophthalmological Center, Yerevan, Armenia

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