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OpenTrials
Completed

NCT Number: NCT01252888

Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents

The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

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Key information

Conditions

Subjects With Primary Open-angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

S.V. Malayna's Ophthalmology Centre

Yerevan, 375108, Armenia

About this study

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.

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

iStents

Device

Implantation of two iStents through a small temporal clear corneal incision

Primary outcomes

  1. mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline

    Time frame: 12 months

Secondary outcomes

  1. Mean diurnal IOP < 18 mmHg at month 12

    Time frame: 12 months

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 Two Trabecular Micro-bypass Stents

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
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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