A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO´s Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)

OPKO Health Inc.,0 个研究点目标入组 0 人开始时间: 2009年3月11日最近更新: 2023年9月4日

研究概览

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•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.

•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).

发起方

OPKO Health Inc.,