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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

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ClinicalTrials.gov Identifier: NCT01455467
Recruitment Status : Active, not recruiting
First Posted : October 20, 2011
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Open-angle Glaucoma Device: One iStent Device: Two iStent Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Study Start Date : September 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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



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


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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)

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

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01455467     History of Changes
Other Study ID Numbers: GCF-024
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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