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

New World Medical

Status: Completed

Conditions: Open Angle Glaucoma

Treatments: Device: Streamline Surgical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05089474

DF6-CL-20-01

Details and patient eligibility

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.

Full description

A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.

Enrollment: 45 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Streamline

Experimental group

Description:

Streamline Surgical System

Treatment:

Device: Streamline Surgical System