A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
- 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
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Streamline Streamline Surgical System Streamline Surgical System
- Primary Outcome Measures
Name Time Method proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12. 12 months Primary Endpoint
- Secondary Outcome Measures
Name Time Method Mean IOP change 12 months Mean IOP change in unmedicated IOP from baseline to M12
Adverse Events 12 months Assess intraoperative and post operative AEs
Number of topical glaucoma medications 12 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