Open Angle Glaucoma
Conditions
Keywords
Open Angle Glaucoma, IOP, viscoelastic
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.
Interventions
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
Sponsors
New World Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized, open label
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12. | 12 months | Primary Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of topical glaucoma medications | 12 months | Number of topical glaucoma medications used at screening compared to Month 12 |
| 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 |
Countries
Costa Rica, Dominican Republic, Mexico
Outcome results
None listed