Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-03

Brief Summary

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Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent

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Detailed Description

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Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

iStent and iStent Supra

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

IOP outcome masked

Study Groups

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G1 plus G3 with phaco

Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra

Group Type EXPERIMENTAL

Cataract surgery plus one iStent and one iStent Supra implanted

Intervention Type DEVICE

Cataract surgery via phacoemulsfication plus one iStent and one iStent supra

Interventions

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Cataract surgery plus one iStent and one iStent Supra implanted

Cataract surgery via phacoemulsfication plus one iStent and one iStent supra

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae

Exclusion Criteria

* Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No