Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

NCT ID: NCT01455467

Last Updated: 2022-08-31

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

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-10-18

Brief Summary

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Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Detailed Description

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Conditions

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Open-angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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One iStent

Implantation of one iStent in conjunction with cataract surgery

Group Type ACTIVE_COMPARATOR

One iStent

Intervention Type DEVICE

Implantation of one iStent in conjunction with cataract surgery

Two iStent

Implantation of two iStent devices in conjunction with cataract surgery

Group Type ACTIVE_COMPARATOR

Two iStent

Intervention Type DEVICE

Implantation of two iStent in conjunction with cataract surgery

Interventions

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One iStent

Implantation of one iStent in conjunction with cataract surgery

Intervention Type DEVICE

Two iStent

Implantation of two iStent in conjunction with cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
* Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

Exclusion Criteria

* Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
* Prior stent implantations (study eye)
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

Other Identifiers

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GCF-024

Identifier Type: -

Identifier Source: org_study_id

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