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CompletedNCT00326066Updated Mar 9, 2018

A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

An interventional study of Glaucoma Surgery and cataract surgery only in Open-Angle Glaucoma, sponsored by Glaukos Corporation. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by Glaukos Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.

Read the detailed description

The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.

02

Conditions studied

  • Open-Angle Glaucoma

Keywords

  • Open angle
  • Glaucoma
  • Surgery
  • Cataract
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 47 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.
  • All subjects must need cataract surgery.

Exclusion criteria

Exclusion Criteria:

  • Angle closure glaucoma
  • Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
  • Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
  • Fellow eye already enrolled
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Active comparator
    1

    Device: Glaucoma Surgery

  • Placebo comparator
    2

    Procedure: cataract surgery only

Interventions

  • DeviceGlaucoma Surgery

    Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.

    Also known as: two Glaukos iStent Trabecular Bypass Microstents

  • Procedurecataract surgery only

    Subjects will undergo routine cataract surgery only (no stent implant).

    Also known as: Phacoemulsification

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What researchers measure

Primary outcomes

  1. Efficacy

    Time frame: 24 months

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Study locations

9 sites
  • Vienna Medical Hospital
    Vienna, A-1090, Austria
  • Mainz University
    Mainz, Germany
  • Augenklinik der Technischen Universitat
    Munich, 81675, Germany
  • Universitats- Augenklinik
    Wurzburg, D-97080, Germany
  • The Netherlands Ophthalmic Research Institute
    Amsterdam, Netherlands
  • Ophthalmic Clinic
    Rotterdam, Netherlands
  • Clinico San Carlos
    Madrid, 28040, Spain
  • Instituto Oftalmológico de Aragón
    Zaragoza, 50007, Spain
  • Beyoglu Eye Research and Education Hospital
    Istanbul, Turkey
08

References and documents

Publications

  • Fernandez-Barrientos Y, Garcia-Feijoo J, Martinez-de-la-Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5. PubMed 20207977 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00326066
Lead sponsor
Glaukos Corporation
Responsible party
Sponsor
First posted
May 16, 2006
Start date
Feb 2005
Primary completion
May 2013
Completion
May 2013
Last update
Mar 9, 2018

Study contacts

Head of Clinical Affairs
study director · Glaukos Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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