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Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

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ClinicalTrials.gov Identifier: NCT01456390
Recruitment Status : Active, not recruiting
First Posted : October 20, 2011
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Device: iStent and iStent supra Not Applicable

Detailed Description:
Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin
Actual Study Start Date : September 2011
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
iStent and iStent supra
Implantation of two iStent devices and one iStent supra device
Device: iStent and iStent supra
Implantation of two iStent devices and one iStent supra device




Primary Outcome Measures :
  1. Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP [ Time Frame: 12 Months ]
    Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit


Secondary Outcome Measures :
  1. Mean diurnal IOP < 18mm Hg [ Time Frame: 12 months ]
    Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit


Other Outcome Measures:
  1. Safety/adverse event monitoring [ Time Frame: 0-61 months ]

    Rate of ocular adverse events through 61 months

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



Information from the National Library of Medicine

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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 patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
  • Open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

  • Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
  • Prior ALT
  • Prior SLT within 90 days of screening visit

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): NCT01456390


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01456390     History of Changes
Other Study ID Numbers: GCF-023
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Glaukos Corporation:
Open angle glaucoma
Prior trabeculectomy

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