Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- SOLX, Inc.
- 入组人数
- 180
- 试验地点
- 29
- 主要终点
- Percentage reduction in IOP at both 12 and 24 months after implant
研究概览
简要总结
Study Objective:
To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.
详细描述
This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
- •Age 21 or over
- •refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery
- •detectable visual field defect (negative MD score)
- •written consent
- •available for up to 24 months follow-up
排除标准
- •either eye with VA worse than count fingers
- •recent angle closure glaucoma episode
- •uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
- •other significant ocular disease, except cataract
- •active ocular infection
- •expected ocular surgery in next 12 months
- •no suitable quadrant for implant
- •systemic corticosteroid therapy > 5 mg/day prednisone
- •intolerance to gonioscopy or other eye exams
- •mental impairment interfering with consent or compliance
- •pregnancy
- •known sensitivity to anticipated medications used at surgery
- •significant co-morbid disease
- •concurrent enrollment in another drug or device study
结局指标
主要结局
Percentage reduction in IOP at both 12 and 24 months after implant
时间窗: 1 & 2 years
次要结局
- Success rate(1 & 2 years)
- Absolute IOP(1 & 2 years)
- Mean number of glaucoma medications(1 & 2 years)