Open Angle GlaucomaVENICENCT05280366
STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma
A study testing Streamline Surgical System and iStent Inject W in people with Open Angle Glaucoma, run by New World Medical, Inc. at 20 sites in 3 countries.
Trial summary
A study of the Streamline Surgical System versus competitor Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Streamline Surgical System and iStent Inject W
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 9 Feb 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Mild to Moderate Primary Open Angle Glaucomma
Who cannot join
- 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.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States18 sites
Georgia Eye Partners
Atlanta, Georgia, 30342
University of Colorado
Aurora, Colorado, 80045
Eye Associates of North New Jersey
Dover, New Jersey, 07927
Vold Vision
Fayetteville, Arkansas, 72704
Ophthalmology Associates
Fort Worth, Texas, 76102
Berkely Eye Center
Houston, Texas, 77027
The Eye Institute
Louisville, Kentucky, 40206
Piedmont Eye Center
Lynchburg, Virginia, 24052
University Eye Specialists
Maryville, Tennessee, 37003
Visionary Research Institute
Newport Beach, California, 92663
Ocala Eye
Ocala, Florida, 34474
Ross Eye Institute
Orchard Park, New York, 14127
Eye Centers of Racine and Kenosha
Racine, Wisconsin, 53405
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
R & R Eye Research
San Antonio, Texas, 78229
Ophthalmology Associates
St Louis, Missouri, 63131
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
Eye Associates Surgical Center
Vineland, New Jersey, 08361
About this study
Official title: 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
A study of the Streamline Surgical System versus competitor
- Conditions
- Open Angle Glaucoma
- Being tested
- Streamline Surgical System, iStent Inject W
- Keywords
- glaucoma, Goniotomy, MIGS
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streamline Surgical SystemDevice
Completion of the Streamline Surgical System procedure
iStent Inject WDevice
Implantation of competitor device
| Study group | Role | What they receive |
|---|---|---|
| Streamline Surgical System | Other | Streamline Surgical System procedure administered Receives: Device: Streamline Surgical System |
| iStent Inject W | Active comparator | iStent Inject W implanted Receives: Device: iStent Inject W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean unmedicated diurnal Intraocular Pressure (IOP)
Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start9 Feb 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New World Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elysia Ison, OD, Study director, New World Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280366
- Sponsor's protocol ID
- DF6-CL-21-02
- Acronym
- VENICE
- Status last verified
- Apr 2024
- First submitted
- 29 Dec 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05280366
- Acronym / sponsor ID
- VENICE / DF6-CL-21-02
- Conditions
- Open Angle Glaucoma
- Keywords
- glaucoma, Goniotomy, MIGS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- New World Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of the Streamline Surgical System versus competitor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Streamline Surgical System | Other | Device: Streamline Surgical SystemStreamline Surgical System procedure administered |
| iStent Inject W | Active comparator | Device: iStent Inject WiStent Inject W implanted |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Mild to Moderate Primary Open Angle Glaucomma
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Streamline Surgical SystemCompletion of the Streamline Surgical System procedure | Device | Streamline Surgical System |
| iStent Inject WImplantation of competitor device | Device | iStent Inject W |
Primary outcome
Change in mean unmedicated diurnal Intraocular Pressure (IOP)
Time frame: 24 months
Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elysia Ison, OD study director
New World Medical, Inc.
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streamline Surgical System and iStent Inject W in people with Open Angle Glaucoma, run by New World Medical, Inc. at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Costa Rica, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean unmedicated diurnal Intraocular Pressure (IOP) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.