A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents 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

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-06-06

Brief Summary

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Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

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Detailed Description

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Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

G2 and G3

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

IOP outcome is masked

Study Groups

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G2 and G3 implantation

Two iStent inject stents and one iStent Supra stent

Group Type OTHER

G2 and G3

Intervention Type DEVICE

Two iStent inject devices and one iStent supra device

Interventions

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G2 and G3

Two iStent inject devices and one iStent supra device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg

Exclusion Criteria

* Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No