This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Open Angle Glaucoma

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

Sponsored by New World Medical, Inc.

About this trial

Last updated 2 years ago

Study ID

DF6-CL-20-01

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
22+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Able to understand and execute written informed consent

2. Males or female subjects at least 22 years of age.

3. Subjects qualifying for cataract surgery

4. Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications

5. Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg

No

Exclusion Criteria

1. Women of child-bearing potential

2. Modified Shaffer angle grade < 2

3. Patients with severe or advanced glaucoma

4. Intraocular surgery within the last 6 months or laser surgery within the last 3 months

5. BCVA worse than 20/80 in either eye

6. Patients with a previous peripheral iridotomy.

7. Ocular infection or inflammation within the last 6 months.

8. Any medication that would be contraindicated for a glaucoma surgical procedure.

Locations

Location

Status