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

NCT ID: NCT01252862

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Detailed Description

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

Conditions

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Subjects With Primary Open-angle Glaucoma (POAG)

Keywords

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Open angle Glaucoma Surgery Ocular Hypertension eye diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Two iStents devices

Two iStents devices will be implanted

Group Type EXPERIMENTAL

iStent

Intervention Type DEVICE

Implantation of two iStents through a small temporal clear corneal incision

Interventions

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iStent

Implantation of two iStents through a small temporal clear corneal incision

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on one topical hypotensive medication

Exclusion Criteria

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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S.V. Malayan's Ophthalmology Centre

Yerevan, , Armenia

Site Status

Countries

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Armenia

References

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Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II, Katz LJ. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015 Nov 3;9:2057-65. doi: 10.2147/OPTH.S91732. eCollection 2015.

Reference Type BACKGROUND
PMID: 26604675 (View on PubMed)

Other Identifiers

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GCF-017

Identifier Type: -

Identifier Source: org_study_id