Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

NCT ID: NCT01444105

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-04-09

Brief Summary

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Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Detailed Description

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Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

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

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

SLT

Laser treatment

Group Type ACTIVE_COMPARATOR

SLT

Intervention Type OTHER

Laser treatment

Interventions

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iStent

Implantation of two iStent devices

Intervention Type DEVICE

SLT

Laser treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
* Primary open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria

* Aphakic or pseudophakic with anterior chamber IOLs (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

References

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Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

Reference Type DERIVED
PMID: 35943114 (View on PubMed)

Other Identifiers

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GCF-028

Identifier Type: -

Identifier Source: org_study_id

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