Post-Market Study of the Argus® II Retinal Prosthesis System - France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Adverse events
研究概览
简要总结
This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.
详细描述
This study is a controlled, prospective, multi-centre, single-arm post-market study. All data collected will be obtained from procedures that are performed as part of routine patient case and from non-interventional questionnaires.
Control will consist of three different matched comparisons:
- Post vs. pre-implantation (Baseline) data.
- Prospective within-subject comparisons (implanted vs. non implanted eye)
- Prospective subjects' visual performance Argus II System ON vs Argus II System OFF.
Subjects participating in the study will undergo a Baseline Visit. The Baseline Visit is performed to screen the subject for eligibility for the device and to collect the study baseline assessments. Assessments include a complete eye examination and medical evaluation, retinal photography and Optical Coherence Tomography, Ultrasound A- and B-scans, the photographic flash test, visual acuity tests, the FLORA and a psychosocial evaluation in order to ensure that the subject has realistic expectations about the system. The NEI-VFQ-25 questionnaire will also be administered.
Subjects who are enrolled in the study will undergo a surgery to have the Argus II device implanted. Following implantation surgery, subjects will return to the clinic for periodic clinical follow-up and device fitting. They will also receive training and visual rehabilitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults, age 25 years or older;
- •Have retinitis pigmentosa with visual acuity of bare light perception or worse in both eyes;
- •Have previous history of useful form vision;
- •If the subject has no residual light perception, the retina must be able to respond to electrical stimulation;
- •The subject is willing to provide written, informed consent to participate in the study.
排除标准
- •Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.);
- •Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.);
- •Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity);
- •Pre-disposition to eye rubbing;
- •Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
- •cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
- •psychiatric disease including diagnosed forms of depression;
- •does not speak a principal language associated with the region, and
- •deafness or selective frequency hearing loss that prevents hearing device alarms and alerts;
- •Pregnant or wish to become pregnant during the course of the study;
- •Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study;
- •Conditions likely to limit life to less than 1 year from the time of inclusion;
- •At the time of the Baseline Visit, suffering from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).
- •Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.);
- •Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.);
- •Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity);
- •Pre-disposition to eye rubbing;
- •Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
- •cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
- •psychiatric disease including diagnosed forms of depression;
- •does not speak a principal language associated with the region, and
- •deafness or selective frequency hearing loss that prevents hearing device alarms and alerts;
- •Pregnant or wish to become pregnant during the course of the study;
- •Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study;
- •Conditions likely to limit life to less than 1 year from the time of inclusion;
- •At the time of the Baseline Visit, suffering from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).
结局指标
主要结局
Adverse events
时间窗: 2 Years
Incidence of procedure- and device-related adverse events
Functional Vision - FLORA
时间窗: 2 Years
The impact of the Argus II on subjects' lives (in terms of functional vision and quality of life) as measured by the Functional Low-vision Observer Rated Assessment (FLORA)
次要结局
- Patient Satisfaction and ease of use of the System(2 years)
- Visual Function(2 years)
- Functional Vision(2 years)
- Explantation rate(2 years)