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Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost

NCT ID: NCT01443988

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-04-30

Brief Summary

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Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Detailed Description

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Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Conditions

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Open-angle Glaucoma

Keywords

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Open angle glaucoma POAG Ocular hypertension Pseudoexfoliative glaucoma Naïve to treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iStent

Implantation of two iStent devices

Group Type ACTIVE_COMPARATOR

iStent

Intervention Type DEVICE

Implantation of two iStent devices

Drug

Travoprost drops

Group Type ACTIVE_COMPARATOR

Travoprost

Intervention Type DRUG

Travoprost drops

Interventions

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iStent

Implantation of two iStent devices

Intervention Type DEVICE

Travoprost

Travoprost drops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Phakic study eye
* IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening)

Exclusion Criteria

* Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
* Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lilit A Voskanyan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

S.V. Malayan Ophthalmological Center, Yerevan, Armenia

Locations

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S.V. Malayan Ophthalmological Center

Yerevan, , Armenia

Site Status

Countries

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Armenia

References

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Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, Ahmed II, Saheb H. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016 Dec;5(2):161-172. doi: 10.1007/s40123-016-0065-3. Epub 2016 Sep 12.

Reference Type BACKGROUND
PMID: 27619225 (View on PubMed)

Other Identifiers

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GCF-022

Identifier Type: -

Identifier Source: org_study_id