A Prospective Evaluation of the Safety and Effectiveness of VividFlo Implantation Using a Partial-Thickness Scleral Flap Technique and The VividFlo System.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
This is a 10-participant study to assess the VividFlo System and surgical implantation using a modified technique.
详细描述
A prospective, single-centre, multi-surgeon, non-comparative clinical study where all participants undergo treatment with a surgical implant (VividFlo) and receive 12 months of follow-up. The intervention is surgical implantation of the VividFlo Glaucoma Implant (VW-51), using the VividFlo System for dissection, mitomycin-C administration and device insertion, and a partial thickness scleral flap over the device stem. The VividFlo System comprises VividFlo and accessory instruments, and is an integrated surgical solution designed to enable precise and reproducible implantation of VividFlo. The aims of this study are to assess the safety and technical skill required for a partial-thickness scleral flap implantation technique; the usability, performance and suitability of the VividFlo System; and the safety and effectiveness of VividFlo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age, Capacity & Consent:
- •Be 18 years of age or older.
- •Be able to understand all study instructions, and willing to comply with all study procedures and the visit schedule.
- •Provide written, informed consent to participate.
- •Glaucoma in the study eye, meeting all of the following requirements:
- •Diagnosed by the investigator, based upon untreated intraocular pressure, disc appearance and visual field abnormalities.
- •The glaucoma type is one of:
- •i. Primary open angle glaucoma (POAG). ii. Chronic angle closure glaucoma (CACG) where the eye is pseudophakic. iii. Mixed mechanism POAG/CACG where a laser iridotomy has previously been performed.
- •iv. Pigmentary open angle glaucoma. v. Exfoliation open angle glaucoma. vi. Neovascular glaucoma that is treated and regressed/quiescent. c. Glaucoma drainage surgery is indicated due to failure of previous treatment (the glaucoma is 'refractory'), with failure of maximum tolerated medical therapy and one of the following circumstances: i. No previous glaucoma surgery. ii. Prior trabecular bypass (using iStents or Hydrus) or cilioablation. iii. Failure of one prior glaucoma drainage operation (that is one of trabeculectomy, deep sclerectomy or Xen).
- •d. The mean diurnal IOP at Baseline is greater than or equal to 20 mmHg and less than or equal to 40 mmHg.
- •e. The conjunctiva in the target quadrant is suitable for glaucoma surgery.
排除标准
- •Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.
- •The glaucoma type is any of the following:
- •Acute Angle Closure Glaucoma (AACG).
- •Chronic Angle Closure Glaucoma (CACG) where the eye is phakic.
- •Congenital glaucoma. Juvenile Open-Angle Glaucoma or Congenital Glaucoma.
- •Secondary glaucoma of any type not specified in the inclusion criteria, including inflammatory glaucoma, active neovascular glaucoma, traumatic glaucoma, Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma.
- •Previous glaucoma surgery with:
- •A tube-and-plate glaucoma drainage implant (GDI, e.g. Molteno, Baerveldt, Paul).
- •A suprachoroidal implant.
- •Multiple previous operations for glaucoma.
- •Glaucoma surgery within 3 months of screening.
- •Cataract surgery or any other ocular surgery is indicated at the time of study intervention or is anticipated to be required during the study duration.
- •Conjunctival scarring or pterygium in the target quadrant.
- •Severe dry eye disease.
- •Significant corneal disease.
- •Accurate measurement of baseline central corneal endothelial density is not possible.
- •Any treatment or condition that, in the opinion of the investigator, may impact corneal endothelial cell density beyond expected age & disease-related decline.
- •Significant retinal or posterior segment pathology, including but not limited to:
- •Active and clinically significant diabetic retinopathy.
- •Active choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy.
- •Intraocular silicone oil.
- •Presence of a scleral buckle.
- •Vitreous present in the anterior chamber.
- •Active uveitis or clinically significant infection or inflammation.
- •Unfit for surgery under local anaesthetic.
- •Any uncontrolled systemic disease.
- •The participant is pregnant, breastfeeding, or cannot guarantee they will not conceive or donate sperm or eggs during the study.
- •Significant risk of bleeding.
- •Any other clinical or social reason that, in the opinion of the investigator, means standard surgical treatment for glaucoma would be considered safer than participation in the study.
研究组 & 干预措施
VividFlo System
Surgical implantation of VividFlo.
干预措施: VividFlo System (Device)
结局指标
主要结局
Primary Outcome
时间窗: 12 months
The proportion of study eyes that meet all the following criteria: 1. Mean diurnal IOP at 12 months is: \<=21 mmHg; and \>=6 mmHg; and reduced by \>=20% compared to baseline. 2. The number of topical IOP-lowering medications at 12 months is the same or fewer than at baseline. 3. At any time during the study, there has been no requirement for: further glaucoma surgery (indicated for efficacy or safety); or systemic/oral IOP-lowering medication for treatment of elevated IOP in the study eye. 4. There have been no adverse events of special significance, defined as: conjunctival erosion; loss of light perception or reduction in best-corrected visual acuity equivalent to doubling of minimum angle of resolution; \>=20% reduction in mean retinal nerve fibre layer attributed to glaucoma; \>=20% reduction in central corneal endothelial cell density attributed to the implant; or Uveitis, Glaucoma and Hyphaema Syndrome.
次要结局
未报告次要终点