Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Change in functional vision
研究概览
简要总结
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.
详细描述
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life. In addition, the study will provide additional information about the safety and efficacy of the CE-certified RETINA IMPLANT Alpha AMS. In several studies it has been shown that patients who received this subretinal implant regain visual function to a certain extent and that its use is safe. So far, all assessments of patients with the RETINA IMPLANT Alpha AMS have been done in a controlled environment within the scope of interventional studies where the benefit in daily life has been assessed anecdotally only. Currently, there is no standard method available for an objective assessment of the impact of such devices in daily life of these patients. Hence, the aim of this study is to further assess the impact in daily life with a combination of already validated and newly developed assessments and questionnaires.
This study adheres to the tenets of the Declaration of Helsinki.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 78
- •Willing and able to give written informed consent
- •Hereditary retinal degeneration of the outer retinal layer i.e. photoreceptors (rods & cones)
- •Pseudophakia or aphakia in the eye to be implanted
- •Retinal vessels with remaining perfusion, despite pathological condition
- •Layering of inner retina in the central region present, as shown by Optical Coherence Tomography (OCT)
- •Thickness of the retina sufficient for subretinal surgery as shown by OCT
- •Inner retina still functional (proven e.g. by light perception or electrically evoked phosphenes (EEP))
- •Blindness in both eyes, (no light perception or light perception only)
- •Visual acuity sufficient for reading normal print in earlier life, optically corrected
- •Period of appropriate visual functions at least 12 years / lifetime
- •Willing and able to perform study assessments and training during the full time period of 12 months
- •Motivation to get the best possible results through training and realistic expectations about these as assessed in screening interview
排除标准
- •OCT shows significant retina edema and/or scar tissue within target region for implant
- •Heavy clumped pigmentation at posterior pole or on the planned route of the implantation
- •atrophy of optic nerve or ganglion cells degeneration
- •Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment)
- •Deep amblyopia reported earlier in life on eye to be implanted
- •Systemic conditions that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/pulmonary diseases, severe metabolic diseases)
- •Acute and severe neurological and/or psychiatric diseases
- •Hyperthyroidism or hypersensitivity to iodine
- •Hypersensitivity to fluorescent dye
- •Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study or women unwilling to perform a pregnancy test before entering the study
- •Participation in another interventional clinical study within the past 30 days
研究组 & 干预措施
RETINA IMPLANT Alpha AMS
All participants receive the subretinal device RETINA IMPLANT Alpha AMS
干预措施: RETINA IMPLANT Alpha AMS (Device)
结局指标
主要结局
Change in functional vision
时间窗: baseline vs. 12 months after implantation
Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation
次要结局
- Vision Related Quality of Life - Questionnaire(at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months))
- Adverse Events(2 years)
- Visual Function - Questionnaire(at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months))
- Measure of implant-mediated visual function(2 years)