| 1. Subjects aged 45 years or older at the Screening Visit
2. Open-angle glaucoma that is uncontrolled by at least 4 classes of ocular hypotensive medications, or fewer in cases where certain medication classes cannot be tolerated and/or are contraindicated and meets at least one of the following criteria:
a. Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt), or
b. Failed one or more cilioablative procedures (with the exception of endocyclophotocoagulation (ECP) or micropulse cyclophotocoagulation (µCPC)).
3. A medicated IOP at the Screening Visit and a mean medicated diurnal IOP at the Baseline Visit of ≥ 20 mmHg and ≤ 40 mmHg
4. Corrected Distance Visual Acuity (CDVA) of light perception or better
5. Glaucomatous optic nerve damage as evidenced by one or more optic disc or retinal nerve fiber layer structural abnormalities, refer to protocol for additional details
6. Glaucomatous visual field defects consistent with optic nerve anomalies, refer to protocol for additional definitions
7. Visible trabecular meshwork with Shaffer Angle Grade ≥ 2.
8. Median central corneal thickness ≥ 460 μm and ≤ 620 μm.
9. Area of free, healthy, and mobile conjunctiva in the target region (superior temporal preferred, but superior nasal permitted) without evidence of subconjunctival fibrosis or anatomical anomaly.
10. Phakic or pseudophakic, refer to protocol for additional details
11. Able to understand the study requirements and provide written informed consent
12. Willing to follow study instructions, agree to comply with all study procedures, and able to return for all scheduled follow-up examinations for at least 12 months postoperatively
|
1. Prior intraocular surgery, exceptions per protocol
2. Non-study eye with Corrected Distance Visual Acuity worse than 20/200
3. Prior Argon Laser Trabeculoplasty, Selective Laser Trabeculoplasty, YAG capsulotomy and YAG vitreolysis within 90 days of Screening
4. Concurrent cataract surgery or anticipated need for cataract surgery, retinal laser procedure or other ocular surgery in the study eye during the 12 months following implantation
5. History of congenital, traumatic, uveitic, neovascular or angle-closure glaucoma or glaucoma associated with vascular disorders
6. Corneal status as follows: a. Active inflammation, b. Clinically significant dystrophy, c. History of corneal surgery with exceptions, d. Corneal opacities that would inhibit visualization in the target region
7. Presence of aphakia, anterior chamber IOL or implantable contact lens
8. Choroidal detachment, effusion, choroiditis, neovascularization or any active choroidopathy
9. Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
10. Elevated episcleral venous pressure or impaired episcleral venous drainage
11. History of hypersensitivity or allergy to any of the device materials/medications used in study
12. Other ocular status per protocol
13. Subject status as follows: a. Uncontrolled systemic disease or completion of chemotherapy, immunotherapy or radiotherapy to the face within 6 months of Screening, b. Inability to potentially discontinue anticoagulation or antiplatelet therapy at the time of surgery
14. Pregnant or nursing women or women of childbearing potential not willing to use contraception throughout the study
15. Patients who have within the previous month, currently or intend to participate in a study with any investigational product
16. Unwilling to discontinue contact lens wear after surgery for the duration of the study
17. Any reason that would increase risks or confound study data per the investigator |
80 and over: 80+ Year,Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
45 Year(s) |
100 Year(s) |
Both |