A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
NCT ID: NCT05089474
Last Updated: 2023-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2021-03-08
2023-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Streamline
Streamline Surgical System
Streamline Surgical System
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
Interventions
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Streamline Surgical System
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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New World Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinica 20/20
San José, CR, Costa Rica
Centro Laser
Santo Domingo, DR, Dominican Republic
Clinica Laser y Ultrasonido Ocular de Puebla
Puebla City, , Mexico
Countries
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Other Identifiers
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DF6-CL-20-01
Identifier Type: -
Identifier Source: org_study_id
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