NCT00834223已完成不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation.
研究概览
简要总结
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). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex will be eligible for the study if all of the following criteria are met:
- •Patients must be aged 18 years or more.
- •Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
- •The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
- •Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
- •Patients must have a BCVA in the fellow eye, which is better than that of the study eye.
- •Patients must be mentally competent and willing to provide informed consent.
- •Patients must be willing to return for all study visits and assessments for at least 3 years after surgery.
- •Exclusion Criteria
- •Patients will not be eligible for the study if any of the following criteria are present:
- •Patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma.
- •Patients with clinically significant corneal disease including corneal dystrophy.
- •Patients with iridocorneal endothelial syndrome.
- •Any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months.
- •Patients with an Anterior Chamber configuration that puts the patient at high risk for the development of angle closure glaucoma.
- •Patients with any recent (within previous 30 days), or current, ocular/periocular inflammation or infection.
- •Patients with a history of extensive keloid formation.
- •Patients who will need ancillary procedures in the study eye at the time of implantation or during the initial one year study period.
- •Patients who have any known intolerance or hypersensitivity to topical anesthetics, mydriatics or components of the device.
- •Patients who are unable to interrupt their anti-coagulant, anti-platelet or NSAID (including aspirin) therapy for at least 3 weeks prior to surgery.
- •Patients who have within the previous 3 months, are currently, or intend to participate in a study with any investigational agent (drug or device).
排除标准
- 未提供
结局指标
主要结局
Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation.
时间窗: 6 and 12 months
次要结局
- Secondary efficacy measure: The change in the number of glaucoma medications from baseline at 6 and 12 months post-implantation.(6 and 12 months)
- Safety measures: The incidence of device and procedure-related complications. All adverse events reported, whether deemed related to the treatment or not.(3 years)
研究者
研究点 (1)
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