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A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent

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ClinicalTrials.gov Identifier: NCT01252914
Recruitment Status : Active, not recruiting
First Posted : December 3, 2010
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Condition or disease Intervention/treatment Phase
Subject With Primary Open-angle Glaucoma (POAG) Device: iStent Supra Stent Phase 4

Detailed Description:
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
Actual Study Start Date : December 2010
Actual Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 1, 2018


Arm Intervention/treatment
Experimental: One iStent Supra Stent and medication
The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma
Device: iStent Supra Stent
Implantation of one iStent Supra Stent through a small temporal clear corneal incision




Primary Outcome Measures :
  1. Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean diurnal Intraocular Pressure < 18 mmHg at month 12 [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Safety [ Time Frame: 0-61 months ]

    Rate of ocular adverse events through 61 months

    • Findings from Intraocular Pressure, best corrected visual acuity, visual field, specular microscopy measurements
    • Findings from slit-lamp, fundus and gonioscopic examinations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252914


Locations
Armenia
S.V. Malayan Ophthalmology Centre
Yerevan, Armenia, 375108
Sponsors and Collaborators
Glaukos Corporation
Investigators
Principal Investigator: Lilit Voskanyan, MD SV Malayan Ophthalmological Center, Yerevan, Armenia

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01252914     History of Changes
Other Study ID Numbers: GCF-019
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Surgery
Ocular Hypertension
Eye Diseases

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antihypertensive Agents