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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Glaukos Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455467
First Posted: October 20, 2011
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Glaukos Corporation
  Purpose
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.

Condition Intervention Phase
Open-angle Glaucoma Device: One iStent Device: Two iStent Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of 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

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP [ Time Frame: 12 Months ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: One iStent
Implantation of one iStent in conjunction with cataract surgery
Device: One iStent
Implantation of one iStent in conjunction with cataract surgery
Active Comparator: Two iStent
Implantation of two iStent devices in conjunction with cataract surgery
Device: Two iStent
Implantation of two iStent in conjunction with cataract surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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): NCT01455467


Locations
Armenia
S.V. Malayan Ophthalmological Center
Yerevan, Armenia, 0001
Sponsors and Collaborators
Glaukos Corporation
Investigators
Principal Investigator: Lilit A Voskanyan, MD, PhD S.V. Malayan Ophthalmological Center, Yerevan, Armenia
  More Information

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01455467     History of Changes
Other Study ID Numbers: GCF-024
First Submitted: September 28, 2011
First Posted: October 20, 2011
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Glaukos Corporation:
Open angle glaucoma
Pigmentary glaucoma
Pseudoexfoliative glaucoma

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