A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Streamline Streamline Surgical System |
Device: Streamline Surgical System
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
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Outcome Measures
Primary Outcome Measures
- proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12. [12 months]
Primary Endpoint
Secondary Outcome Measures
- Adverse Events [12 months]
Assess intraoperative and post operative AEs
- Mean IOP change [12 months]
Mean IOP change in unmedicated IOP from baseline to M12
- Number of topical glaucoma medications [12 months]
Number of topical glaucoma medications used at screening compared to Month 12
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to understand and execute written informed consent
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Males or female subjects at least 22 years of age.
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Subjects qualifying for cataract surgery
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Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
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Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg
Exclusion Criteria:
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Women of child-bearing potential
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Modified Shaffer angle grade < 2
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Patients with severe or advanced glaucoma
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Intraocular surgery within the last 6 months or laser surgery within the last 3 months
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BCVA worse than 20/80 in either eye
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Patients with a previous peripheral iridotomy.
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Ocular infection or inflammation within the last 6 months.
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Any medication that would be contraindicated for a glaucoma surgical procedure.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinica 20/20 | San José | CR | Costa Rica | 10108 |
2 | Centro Laser | Santo Domingo | DR | Dominican Republic | 10124 |
3 | Clinica Laser y Ultrasonido Ocular de Puebla | Puebla | Mexico | 72530 |
Sponsors and Collaborators
- New World Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DF6-CL-20-01