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

Not Applicable
Completed
Conditions
Open Angle Glaucoma
Interventions
Device: Streamline Surgical System
Registration Number
NCT05089474
Lead Sponsor
New World Medical, Inc.
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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
StreamlineStreamline Surgical SystemStreamline Surgical System
Primary Outcome Measures
NameTimeMethod
proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.12 months

Primary Endpoint

Secondary Outcome Measures
NameTimeMethod
Mean IOP change12 months

Mean IOP change in unmedicated IOP from baseline to M12

Adverse Events12 months

Assess intraoperative and post operative AEs

Number of topical glaucoma medications12 months

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

Trial Locations

Locations (3)

Clinica 20/20

🇨🇷

San José, CR, Costa Rica

Centro Laser

🇩🇴

Santo Domingo, DR, Dominican Republic

Clinica Laser y Ultrasonido Ocular de Puebla

🇲🇽

Puebla, Mexico

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