None listed
Conditions
Interventions
Aquashunt Type of group
All subjects receive device. A shunt which is surgically implanted into the suprachoroidal space.
Sponsors
OPKO Health Inc.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • The patient must be 18 years of age or older. • The patient must have a diagnosis of chronic forms of open-angle glaucoma in the study eye, which is not controllable with the maximum medical treatment tolerated with ocular hypotensive drugs and that has failed in glaucoma surgery or is not considered a candidate Reasonable for traditional surgery. • The patient´s documented IOP must be considered by the treating physician as too high for his glaucoma status. • The patient must have a MAVC between 20/400 and perception of light, or not having, perception of light with pain, in the eye of the study, • The patient must have a MAVC in the other eye better than the study eye. • The patient must be mentally competent and willing to give informed consent. • The patient must be willing to return for all study visits and evaluations for at least 3 years after surgery.
Exclusion criteria
Exclusion criteria: • The patient has a diagnosis of glaucoma other than open-angle glaucoma, including active uveitic glaucoma, active neovascular or traumatic recent. • Patients with a clinically significant corneal condition, including corneal dystrophy. • Patients with iridocorneal endothelial syndrome. • Any previous eye surgery, except trabeculectomy, trabeculoplasty or cataract surgery, or any surgery (including laser) in the previous 3 months. • Patients with an anterior chamber configuration that puts them at high risk of developing angle closure glaucoma. • Patients with any recent (last 30 days) or current ocular or periocular inflammation or infection. • Patients with a history of considerable keloid formation. • Patients who require ancillary procedures in the eye of the study at the time of implantation or during the first year of the study period. • Patients with any known intolerance or hypersensitivity to topical anesthetics, media agents or components of the device. • Patients who cannot interrupt their anticoagulant, antiplatelet or FAINE therapy (including aspirin) for at least 3 weeks prior to surgery. • Patients who have participated in the last three months, are participating or intend to participate in a study with any investigating agent (drug or device).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Using the Standard technique for Goldmann flattening tonometry Measure:The percentage change in IOP from baseline to 6 months and 12 months post-implantation. Timepoints:6 months and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Review of the amount of glaucoma medications used. Measure:Change in the amount of medications for glaucoma from initial to 6 and 12 months. Timepoints:6 and 12 months. ; Outcome name:All adverse events will be evaluated from their appearance, and the evaluation will continue until its resolution is noticed, or until the investigator determines that the patients condition is stable. Measure:Incidence of complications related to the device and procedure. Timepoints:During the study ; Outcome name:All adverse events will be evaluated from their appearance, and the evaluation will continue until its resolution is noticed, or until the investigator determines that the patients condition is stable. Measure:Incidence of reported adverse effects, whether or not they are related to the treatment. Timepoints:During the study | — |
Countries
Dominican Republic, Peru
Contacts
Public ContactJuan Batlle
INSTITUTO REGIONAL DE OFTALMOLOGIA
Outcome results
None listed