A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma

NCT05089474 | Completed

• 1 other identifier: DF6-CL-20-01
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 3

Brief Summary

A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.

Conditions

Open Angle Glaucoma

Keywords

Open Angle Glaucoma, IOP, viscoelastic

Outcome Measures

Primary Outcomes (1)

• proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.

  Primary Endpoint

  12 months

Secondary Outcomes (3)

• Adverse Events

  12 months

• Mean IOP change

  12 months

• Number of topical glaucoma medications

  12 months

Study Arms (1)

Streamline

EXPERIMENTAL

Streamline Surgical System

Device: Streamline Surgical System

Interventions

Streamline Surgical System DEVICE

The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.

Streamline

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and execute written informed consent
• Males or female subjects at least 22 years of age.
• Subjects qualifying for cataract surgery
• Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
• Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg

You may not qualify if:

• Women of child-bearing potential
• Modified Shaffer angle grade \< 2
• Patients with severe or advanced glaucoma
• Intraocular surgery within the last 6 months or laser surgery within the last 3 months
• BCVA worse than 20/80 in either eye
• Patients with a previous peripheral iridotomy.
• Ocular infection or inflammation within the last 6 months.
• Any medication that would be contraindicated for a glaucoma surgical procedure.

Sponsors & Collaborators

• New World Medical, Inc.: lead

Study Sites (3)

Clinica 20/20

San José, CR, 10108, Costa Rica

Location

Centro Laser

Santo Domingo, DR, 10124, Dominican Republic

Location

Clinica Laser y Ultrasonido Ocular de Puebla

Puebla City, 72530, Mexico

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, open label

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 22, 2021
• Study Start: March 8, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); ME (1); CO (1)