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OpenTrials
Completed

NCT Number: NCT01252914

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

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.

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Key information

Conditions

Subject With Primary Open-angle Glaucoma (POAG) Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

S.V. Malayan Ophthalmology Centre

Yerevan, 375108, Armenia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iStent Supra Stent

Device

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

Primary outcomes

  1. Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline

    Time frame: 12 months

Secondary outcomes

  1. Mean diurnal Intraocular Pressure < 18 mmHg at month 12

    Time frame: 12 months

Other outcomes

  1. Safety

    Time frame: 0-61 months

    Rate of ocular adverse events through 61 months

    • Findings from Intraocular Pressure, best corrected visual acuity, visual field, specular microscopy measurements
    • Findings from slit-lamp, fundus and gonioscopic examinations

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2010
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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