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STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma

A Prospective, Randomized, Multi-center Evaluation of the Safety and Effectiveness of the STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05280366
Acronym
VENICE
Enrollment
150
Registered
2022-03-15
Start date
2022-02-09
Completion date
2026-06-30
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma

Keywords

glaucoma, Goniotomy, MIGS

Brief summary

A study of the Streamline Surgical System versus competitor

Interventions

DEVICEStreamline Surgical System

Completion of the Streamline Surgical System procedure

DEVICEiStent Inject W

Implantation of competitor device

Sponsors

New World Medical, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of Mild to Moderate Primary Open Angle Glaucomma

Exclusion criteria

* Other types of glaucoma including but not limited to: Normal tension glaucoma, pseudoexfoliative glaucoma, narrow angle glaucoma, traumatic, congenital, malignant, uveitic or neovascular glaucoma. Ocular hypertension.

Design outcomes

Primary

MeasureTime frameDescription
Change in mean unmedicated diurnal Intraocular Pressure (IOP)24 monthsChange in mean unmedicated diurnal Intraocular Pressure (IOP) over time

Countries

Costa Rica, Mexico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026