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

NCT ID: NCT01252888

Last Updated: 2022-09-07

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

39 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 assess efficacy and safety of two iStents for the reduction of intraocular pressure associated 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)

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 iStent devices and medication

Implantation of two iStents through small temporal clear corneal incision

Group Type EXPERIMENTAL

iStents

Intervention Type DEVICE

Implantation of two iStents through a small temporal clear corneal incision

Interventions

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iStents

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)
* Subjects on two topical hypotensive medications

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. Malayna's Ophthalmology Centre

Yerevan, , Armenia

Site Status

Countries

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Armenia

References

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Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, Samuelson TW. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg. 2014 Aug;40(8):1295-300. doi: 10.1016/j.jcrs.2014.07.004.

Reference Type BACKGROUND
PMID: 25088627 (View on PubMed)

Chang DF, Donnenfeld ED, Katz LJ, Voskanyan L, Ahmed II, Samuelson TW, Giamporcaro JE, Hornbeak DM, Solomon KD. Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up. Clin Ophthalmol. 2017 Mar 15;11:523-528. doi: 10.2147/OPTH.S121041. eCollection 2017.

Reference Type BACKGROUND
PMID: 28352151 (View on PubMed)

Other Identifiers

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GCF-018

Identifier Type: -

Identifier Source: org_study_id

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