Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-21

Study Completion Date

2017-06-22

Brief Summary

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The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).

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Detailed Description

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The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase.

Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye.

Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.

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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CyPass

CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye

Group Type ACTIVE_COMPARATOR

CyPass Micro-Stent

Intervention Type DEVICE

Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.

CyPass30

CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic

Group Type EXPERIMENTAL

CyPass Micro-Stent

Intervention Type DEVICE

Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.

Viscoelastic

Intervention Type DEVICE

Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent

CyPass60

CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic

Group Type EXPERIMENTAL

CyPass Micro-Stent

Intervention Type DEVICE

Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.

Viscoelastic

Intervention Type DEVICE

Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent

Interventions

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CyPass Micro-Stent

Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.

Intervention Type DEVICE

Viscoelastic

Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent

Intervention Type DEVICE

Other Intervention Names

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Model 2FX

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open angle glaucoma;
* Unmedicated IOP between 21 - 36 mmHg, inclusive;
* Normal angle anatomy at site of intended CyPass Micro-Stent implantation.

Exclusion Criteria

* Advanced glaucoma;
* Prior incisional glaucoma surgery;
* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
* Clinically significant ocular pathology other than glaucoma.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No