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

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ClinicalTrials.gov Identifier: NCT01444105
Recruitment Status : Active, not recruiting
First Posted : September 30, 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 two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Device: iStent Other: SLT Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
Study Start Date : September 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: iStent
implantation of two iStent devices
Device: iStent
Implantation of two iStent devices

Active Comparator: SLT
Laser treatment
Other: SLT
Laser treatment




Primary Outcome Measures :
  1. Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit. [ Time Frame: 12 Months ]


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

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)

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): NCT01444105


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

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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01444105     History of Changes
Other Study ID Numbers: GCF-028
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Keywords provided by Glaukos Corporation:
Open angle glaucoma
Pseudoexfoliative glaucoma

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