NCT01490827终止不适用
Argus® II Retinal Prosthesis System Post-Market Surveillance Study
Second Sight Medical Products10 个研究点 分布在 2 个国家目标入组 52 人开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- adverse events
研究概览
简要总结
This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.
详细描述
This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.
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
- •Adults, age 25 year or older
- •with severe to profound outer retinal degeneration (not including Age-related Macular Degeneration)
- •Have some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation;
- •Have previous history of useful form vision
- •Have consented to participate in the study
- •Had an Argus II Retinal Prosthesis surgically implanted 14 days (± 7 days) prior to enrollment (at Baseline Visit) in the study
- •At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).
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
- •Participants who are pregnant or wish to become pregnant during the course of the study
- •Participation 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.
结局指标
主要结局
adverse events
时间窗: up to 3 years from time of implantation
nature and rate of adverse events
次要结局
- visual function(up to 3 years from time of implantation)
研究者
研究点 (10)
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