A Prospective Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of ARGOS-IO System in Patients Undergoing Implantation of a Boston Keratoprosthesis (BKPro)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)
研究概览
简要总结
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is intended to be used together with the hand-held Mesograph reading device to telemetrically measure the intraocular pressure (IOP) of patients with a BKPro.
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the 12 month period beginning at implantation.
详细描述
(see above)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 18 and ≤ 80 years on the day of screening
- •Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularized cornea AND either a verifiable history of two or more prior failed corneal transplant procedures or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely. Potential study subjects will be solicited for participation in the clinical trial only after they have consented to the keratoprosthesis operation.
- •Axial length > 21 mm
- •Ability and willingness to attend all scheduled visits and comply with all study procedures
排除标准
- •Reasonable chance of success with traditional keratoplasty
- •Current retinal detachment
- •Connective tissue diseases
- •History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to ARGOS-IO implantation
- •History of ocular or periocular malignancy
- •History of extensive keloid formation
- •Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device)
- •Presence of another active medical eye implant and/or other active medical implants in the head/neck region
- •Signs of current infection, including fever and current treatment with antibiotics
- •Severe generalized disease that results in a life expectancy shorter than a year
- •Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
- •Currently pregnant or breastfeeding
- •Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device
- •Intraoperative complication that would preclude implantation of the study device
- •Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.
- •Previous or concurrent enrollment of the contralateral eye in this clinical study.
研究组 & 干预措施
ARGOS-IO system
The ARGOS-IO system is a non-European Community (CE) marked investigational medical device composed of the implant and its accessories.
Implant: ARGOS-IO pressure sensor implant for sulcus placement or transcleral fixation
Accessories: MESOGRAPH reading device, Implant Injector
干预措施: ARGOS-IO system (Device)
结局指标
主要结局
Safety and Tolerability: Number of Patients Experiencing a Device Related SAE (SADE)
时间窗: Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.
Number of patients experiencing a device-related SAE (SADE).
Performance: Performance of the ARGOS-IO System Compared to Manometry
时间窗: Assessed at visits Week 4, Week 16, Week 28 and Week 52, final status at Week 52 reported.
Consistency between manometric and telemetric IOP obtained by the ARGOS-IO system.
次要结局
- Performance: Correlation Between Finger Palpation and the ARGOS-IO System(Assessed at visits from Day 1 through Week 52, final status at Week 52 reported.)
- Safety and Tolerability: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.(Assessed at visits from Day 0 [Implantation] through Week 52, final status at Week 52 reported.)
- Usability: User Acceptance at Home(Assessed at visit Week 52, final status at Week 52 reported.)