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Device

Streamline Surgical System vs iStent for Open-Angle Glaucoma (VENICE Trial)

N/A
Recruiting
Research Sponsored by New World Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Mild to Moderate Primary Open Angle Glaucomma
Be older than 18 years old
Must not have
Ocular hypertension.
Other types of glaucoma including but not limited to: Normal tension glaucoma, pseudoexfoliative glaucoma, narrow angle glaucoma, traumatic, congenital, malignant, uveitic or neovascular glaucoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial compared the Streamline Surgical System to a competitor for use in surgeries.

Who is the study for?
This trial is for people with mild to moderate Primary Open-Angle Glaucoma. It's not open to those with other glaucoma types like normal tension, pseudoexfoliative, narrow angle, traumatic, congenital, malignant, uveitic or neovascular glaucoma or just ocular hypertension.
What is being tested?
The study compares two treatments for Open-Angle Glaucoma: the Streamline Surgical System and iStent Inject W. Patients will receive one of these interventions to see which is more effective.
What are the potential side effects?
Potential side effects are not specified in the provided information. Generally, surgical interventions for glaucoma may include risks such as infection, bleeding inside the eye (hyphema), increased eye pressure or vision loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with mild to moderate open-angle glaucoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have high eye pressure.
Select...
I have a specific type of glaucoma, not the most common one.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in mean unmedicated diurnal Intraocular Pressure (IOP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Streamline Surgical SystemExperimental Treatment1 Intervention
Streamline Surgical System procedure administered
Group II: iStent Inject WActive Control1 Intervention
iStent Inject W implanted
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Streamline Surgical System
2021
N/A
~50

Find a Location

Who is running the clinical trial?

New World Medical, Inc.Lead Sponsor
7 Previous Clinical Trials
455 Total Patients Enrolled
Elysia Ison, ODStudy DirectorNew World Medical, Inc.

Media Library

iStent Inject W (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05280366 — N/A
Open-Angle Glaucoma Research Study Groups: Streamline Surgical System, iStent Inject W
Open-Angle Glaucoma Clinical Trial 2023: iStent Inject W Highlights & Side Effects. Trial Name: NCT05280366 — N/A
iStent Inject W (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280366 — N/A
~55 spots leftby Jun 2026
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