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

Not Applicable

Active, not recruiting

• Conditions: Open Angle Glaucoma
• Interventions: Device: Streamline Surgical System; Device: iStent Inject W

• Registration Number: NCT05280366
• Lead Sponsor: New World Medical, Inc.

Brief Summary

A study of the Streamline Surgical System versus competitor

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study Start: 2022-02-09
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Diagnosis of Mild to Moderate Primary Open Angle Glaucomma

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Streamline Surgical System	Streamline Surgical System	Streamline Surgical System procedure administered
iStent Inject W	iStent Inject W	iStent Inject W implanted

Primary Outcome Measures

Name	Time	Method
Change in mean unmedicated diurnal Intraocular Pressure (IOP)	24 months	Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time

Trial Locations

Locations (19)

R & R Eye Research; 🇺🇸 San Antonio, Texas, United States

Clinica Laser y Ultrasonido Ocular; 🇲🇽 Puebla, Mexico

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

Visionary Research Institute; 🇺🇸 Newport Beach, California, United States

Wolstan and Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Ocala Eye; 🇺🇸 Ocala, Florida, United States

Georgia Eye Partners; 🇺🇸 Atlanta, Georgia, United States

The Eye Institute; 🇺🇸 Louisville, Kentucky, United States

Ophthalmology Associates; 🇺🇸 Fort Worth, Texas, United States

Eye Associates of North New Jersey; 🇺🇸 Dover, New Jersey, United States

Eye Associates Surgical Center; 🇺🇸 Vineland, New Jersey, United States

Ross Eye Institute; 🇺🇸 Orchard Park, New York, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

University Eye Specialists; 🇺🇸 Maryville, Tennessee, United States

Berkely Eye Center; 🇺🇸 Houston, Texas, United States

Piedmont Eye Center; 🇺🇸 Lynchburg, Virginia, United States

Eye Centers of Racine and Kenosha; 🇺🇸 Racine, Wisconsin, United States

Clinica 20/20; 🇨🇷 San José, Costa Rica