A Prospective, Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-IO System in Patients With Primary Open Angle Glaucoma (POAG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 22
- 主要终点
- Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
详细描述
This prospective, open-label, multi center, single-arm clinical investigation will enroll 22 consecutive patients.
Enrollment will be temporarily halted in case a serious adverse device effect (SADE) occurs, and Data and Safety Monitoring Board (DSMB) meeting will be conducted as soon as possible. The DSMB will then recommend whether to further continue the study as planned, or whether enrollment shall be stopped. In order to provide a complete overview of the study to the DSMB, an interim analysis will be performed after half of the study population (11-14 subjects) is enrolled with a minimum follow-up of 1 month. A conclusion for safety will be made if in total no more than 2 of the total of 22 patients experience a SADE.
The primary aim of this study is to show "safety", which will be evaluated based on the percentage of subjects who experience a SADE (="non-safety"), as defined in the primary endpoints.
The study will be declared a success if the final non-safety event rate is less than 6% (type II error rate of 0.20). The calculation is based on a design optimizing the minimum expected sample size with parameters alpha=0.05, beta=0.20, p0=0.75, p1=0.94.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mentally competent and willing to provide written informed consent
- •Male or female aged ≥40 and ≤85 years. Female subjects of childbearing potential must be willing to use adequate contraception and must have a negative pregnancy test.
- •Diagnosis of primary open-angle glaucoma (POAG) including high pressure glaucoma (HPG), normal pressure glaucoma (NPG) and ocular hypertension (OH), as defined by the European Glaucoma Society guideline (Heijl, Treverso, et al., 2008)
- •Sufficiently controlled intraocular pressure (IOP)
- •Study eye needs to be phakic
- •Only one eye per patient may be implanted with the ARGOS-IO implant
- •Cataract surgery indicated. The medical indication for a cataract operation must be given irrespective of the study participation. Potential study patients will be solicited for participation in the clinical trial only after the patient has given consent to the cataract operation.
- •Pre-operative anterior chamber depth (ACD) ≥2.0 mm as measured from the corneal endothelium
- •Axis length >22 mm
- •Endothelial cell density of the cornea ≥2000 cells/mm²
- •Subjects able and willing to attend all scheduled visits and comply with all study procedures
排除标准
- •Any other type of glaucoma other than primary open-angle glaucoma as defined by inclusion criterion 3
- •Severe POAG patients with a macular degeneration and visual field loss of -20 decibels (dB) or worse in both eyes. In case of a diverse developed visual field loss, the sensor can be implanted in the worse eye for protection the better eye.
- •Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
- •Retinal detachment
- •Corneal diseases, especially diseases affecting the corneal endothelium, e.g. Fuchs' Dystrophia
- •Diabetes mellitus
- •Existence of Marfan-Syndrome, Ehlers-Danlos-Syndrome or Weill-Marchesani-Syndrome
- •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
- •Intraocular surgical procedure(s) within 6 months prior to ARGOS-IO implantation or any surgical procedure such as refractive eye surgery in the study eye that can affect the assessment of IOP by Goldmann applanation tonometry
- •History of eye tumor
- •Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP by Goldmann applanation tonometry (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy)
- •Anterior chamber configuration that puts the subject at high risk to develop an angle closure glaucoma
- •History of extensive keloid formation
- •Severe dry eye syndrome
- •Subjects who will need to undergo ancillary procedures in the study eye at the time of implantation or during the post-operative study period
- •Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, plaster or silicone (component of the device)
- •Existence of other active medical eye implant and/or other active medical implants in the head/neck region
- •Any contraindication for intraocular lens (IOL) implantation such as choroidal hemorrhage, concomitant severe eye disease, excessive vitreous loss, extremely shallow anterior chamber, microphthalmos, non-age-related cataract, posterior capsular rupture, severe corneal dystrophy, untraceable IOP, zonular separation, color vision deficiencies
- •Severe generalized disease resulting 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
- •Patients who are not suitable for the study based on the surgeon's evaluation
- •Patients unable or unwilling to understand or comply with required study procedures
- •Patients with psychiatric disorders influencing their judgement or autonomy
- •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.
- •Enrollment of the fellow eye in this clinical study
研究组 & 干预措施
Single-arm intervention ARGOS-IO system
The ARGOS-IO Pressure sensor will be additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery.
干预措施: ARGOS-IO system (Device)
结局指标
主要结局
Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
时间窗: Day 0 to Day 360 (V01 [Implantation] to V11)
Number of patients experiencing a device related SAE (SADE) and complications during the implantation of the ARGOS-IO device.
Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System
时间窗: Day 30 to Day 360 (V05 to V11)
Intraclass correlation between intraocular pressure (IOP) measurements made by GAT and the ARGOS-IO system (IOP in mmHg; starting at visit V05 as specified by the protocol) following the ICC(3,k) concordance analysis method \[Choritz et al., 2019 (Telemetric Measurement of ... ARGOS-02 Trial) in the "References"-section\].
次要结局
- Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.(Day 0 to Day 360 (V01 [Implantation] to V11))