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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Open-Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Glaucoma Surgery

Intervention Type DEVICE

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.

2

Group Type PLACEBO_COMPARATOR

cataract surgery only

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DEVICE

cataract surgery only

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

Intervention Type PROCEDURE

Other Intervention Names

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two Glaukos iStent Trabecular Bypass Microstents Phacoemulsification

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No