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NCT Number: NCT05089474

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

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.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica 20/20, San José, CR, Costa Rica

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Streamline Surgical System

Device

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

Primary outcomes

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

    Time frame: 12 months

    Primary Endpoint

Secondary outcomes

  1. Adverse Events

    Time frame: 12 months

    Assess intraoperative and post operative AEs

  2. Mean IOP change

    Time frame: 12 months

    Mean IOP change in unmedicated IOP from baseline to M12

  3. Number of topical glaucoma medications

    Time frame: 12 months

    Number of topical glaucoma medications used at screening compared to Month 12

Sponsors and collaborators

Lead sponsor

New World Medical, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2021
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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