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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01444105
First received: September 28, 2011
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Open-angle Glaucoma
Device: iStent
Other: SLT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

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: iStent
implantation of two iStent devices
Device: iStent
Implantation of two iStent devices
Active Comparator: SLT
Laser treatment
Other: SLT
Laser treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444105

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

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01444105     History of Changes
Other Study ID Numbers: GCF-028
Study First Received: September 28, 2011
Last Updated: March 28, 2013
Health Authority: Armenia: Armenian Ministry of Health

Keywords provided by Glaukos Corporation:
Open angle glaucoma
Pseudoexfoliative glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014