VENICE: STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma
Sponsor
New World Medical, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05280366
Collaborator
(none)
150
1
2
34.7
4.3
Study Details
Study Description
Brief Summary
A study of the Streamline Surgical System versus competitor
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Feb 9, 2022
Anticipated Primary Completion Date
:
Dec 30, 2024
Anticipated Study Completion Date
:
Dec 30, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Streamline Surgical System Streamline Surgical System procedure administered |
Device: Streamline Surgical System
Completion of the Streamline Surgical System procedure
|
| Active Comparator: iStent Inject W iStent Inject W implanted |
Device: iStent Inject W
Implantation of competitor device
|
Outcome Measures
Primary Outcome Measures
- Change in mean unmedicated diurnal Intraocular Pressure (IOP) [24 months]
Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time
Eligibility Criteria
Criteria
Ages Eligible for Study:
22 Years
and Older
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York Eye Surgery Associates | Bronx | New York | United States | 10469 |
Sponsors and Collaborators
- New World Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
New World Medical, Inc.
ClinicalTrials.gov Identifier:
NCT05280366
Other Study ID Numbers:
- DF6-CL-21-02
First Posted:
Mar 15, 2022
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by New World Medical, Inc.
Additional relevant MeSH terms: