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NCT00326066 Clinical Trial

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

Open-Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00326066
Other study ID # GCF-007
Secondary ID
Status Completed
Phase N/A
First received May 12, 2006
Last updated March 7, 2018
Start date February 2005
Est. completion date May 2013

Study information
Verified date March 2018
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria Vienna Medical Hospital Vienna
Germany Mainz University Mainz
Germany Augenklinik der Technischen Universitat Munich
Germany Universitats- Augenklinik Wurzburg
Netherlands The Netherlands Ophthalmic Research Institute Amsterdam
Netherlands Ophthalmic Clinic Rotterdam
Spain Clinico San Carlos Madrid
Spain Instituto Oftalmológico de Aragón Zaragoza
Turkey Beyoglu Eye Research and Education Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  Spain,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy 24 months
See also
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Completed NCT01455467 - Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery N/A
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Completed NCT01699464 - A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months Phase 2