Eye Diseases
Conditions
Interventions
VisiPlate Aqueous Shunt
Sponsors
Avisi Technologies Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The first co-primary effectiveness outcome is the proportion of subjects (eyes) achieving a = 20% reduction in MDIOP at Month 12 while maintaining the same or fewer number of ocular hypotensive medication classes compared to the Baseline Visit. a.The proportion of eyes achieving the primary effectiveness outcome will be calculated with the corresponding 95% confidence interval. 2.The second co-primary effectiveness outcome is the reduction in MDIOP (mmHg) at Month 12 compared to the Baseline Visit. a.The MDIOP change at Month 12 from the baseline will be calculated with the corresponding 95% confidence interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percent change in MDIOP at Month 12 compared to the Baseline Visit. a. The MDIOP percent change at Month 12 from the baseline will be calculated with the corresponding 95% confidence interval. 2. The mean reduction in the number of ocular hypotensive medication classes at Month 12 compared to the Baseline Visit. a. The mean reduction in the number of ocular hypotensive medication classes at Month 12 from the baseline will be calculated with the corresponding 95% confidence interval.;KEY SAFETY OUTCOMES Key safety will be summarized by study visit for the study eye and will include: • Incidence and severity of ocular adverse events (intraoperative, postoperative) • BCDVA • Incidence of lens opacities or worsening of pre-existing lens opacities (phakic eyes only) • Slit lamp biomicroscopy findings • Fundus examination findings • Visual field measurements • Gonioscopic examination findings • Pachymetry | — |
Countries
South Africa
Contacts
Public ContactMorne De Bruin
Consultant and Regional Monitor
Outcome results
None listed