NCT07730424已完成不适用
A Feasibility Clinical Study to Evaluate the Safety and Effectiveness of the VividWhite Glaucoma Implant (VW-50) for the Treatment of Glaucoma.
Melbourne Eye Specialists1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年8月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary feasibility outcome
研究概览
简要总结
An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50.
详细描述
A single-centre, investigator-initiated device Feasibility Study where 10 participants undergo glaucoma surgery for implantation of a novel implant (VW-50) and receive 12 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age - greater than 18 years of age.
- •Glaucoma - as diagnosed by the investigator based upon untreated intraocular pressure, disc appearance, and visual field abnormalities.
- •Failed medical treatment - In the opinion of the investigator, the IOP is uncontrolled in the study eye after having failed previous medical treatment.
- •Conjunctival health - In the opinion of the investigator the participant should have a healthy, free, and mobile conjunctiva in the target quadrant.
- •Capable - Ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.
排除标准
- •Prior glaucoma surgery in the study eye.
- •Advanced glaucomatous optic nerve damage which, in the opinion of the investigator, threatens fixation and/or standard surgery would be considered safer.
- •Active neovascular glaucoma, Iridocorneal Endothelial (ICE) Syndrome, traumatic glaucoma, silicone oil induced glaucoma, active acute angle closure glaucoma or subluxation of the lens.
- •Active diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy, or other ophthalmic disease or disorder in the study eye that could confound study results.
- •Any condition of the cornea that could confound study results or would preclude accurate readings with an applanation tonometer and/or a contact pachymeter.
- •Visually significant cataract in the study eye that will not be removed at the time of implantation.
- •BCVA worse than 6/30 (Snellen equivalent)
- •Clinically significant inflammation or infection in either eye
- •Unfit for local anaesthetic surgery.
- •Any uncontrolled systemic disease.
- •Female participants who are pregnant, nursing, or planning a pregnancy during the study, or who are of childbearing potential and not using a reliable means of contraception during the study.
- •Significant risk of bleeding.
结局指标
主要结局
Primary feasibility outcome
时间窗: At study intervention
Assessment of the ease of implantation of VW-50 in the human eye, measured by surgeon questionnaire assessment of implantation technique (custom 11-item questionnaire with 5 responses selectable per item, ranging from 'strongly disagree' to 'strongly agree')
次要结局
- Secondary feasibility outcome 1(At study intervention)
- Secondary feasibility outcome 2(12 months)
- Safety and tolerability outcome 1(12 months)
- Safety and tolerability outcome 2(12 months)
- Safety and tolerability outcome 3(12 months)
- Safety and tolerability outcome 4(12 months)
- Efficacy outcome 1(12 months)
- Efficacy outcome 2(12 months)
研究者
研究点 (1)
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