A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
This study is ongoing, but not recruiting participants.
Sponsor:
Glaukos Corporation
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00326066
First received: May 12, 2006
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Open-Angle Glaucoma |
Device: Glaucoma Surgery Procedure: cataract surgery only |
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 Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension |
Resource links provided by NLM:
Further study details as provided by Glaukos Corporation:
Primary Outcome Measures:
- Efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Device: Glaucoma 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.
Other Name: two Glaukos iStent Trabecular Bypass Microstents
|
| Placebo Comparator: 2 |
Procedure: cataract surgery only
Subjects will undergo routine cataract surgery only (no stent implant).
Other Name: Phacoemulsification
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326066
Locations
| Austria | |
| Vienna Medical Hospital | |
| Vienna, Austria, A-1090 | |
| Germany | |
| Mainz University | |
| Mainz, Germany | |
| Augenklinik der Technischen Universitat | |
| Munich, Germany, 81675 | |
| Universitats- Augenklinik | |
| Wurzburg, Germany, D-97080 | |
| Netherlands | |
| The Netherlands Ophthalmic Research Institute | |
| Amsterdam, Netherlands | |
| Ophthalmic Clinic | |
| Rotterdam, Netherlands | |
| Spain | |
| Clinico San Carlos | |
| Madrid, Spain, 28040 | |
| Instituto Oftalmológico de Aragón | |
| Zaragoza, Spain, 50007 | |
| Turkey | |
| Beyoglu Eye Research and Education Hospital | |
| Istanbul, Turkey | |
Sponsors and Collaborators
Glaukos Corporation
Investigators
| Study Director: | Head of Clinical Affairs | Glaukos Corporation |
More Information
No publications provided
| Responsible Party: | Glaukos Corporation |
| ClinicalTrials.gov Identifier: | NCT00326066 History of Changes |
| Other Study ID Numbers: | GCF-007 |
| Study First Received: | May 12, 2006 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Glaukos Corporation:
|
Open angle Glaucoma Surgery Cataract |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension |
Cataract Eye Diseases Lens Diseases |
ClinicalTrials.gov processed this record on May 22, 2013