Study of the WA-NG (NG-IMT) Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-Stage Age Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)
研究概览
简要总结
The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
详细描述
Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition.
Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with bilateral, stable, moderate to profound central vision impairment due to bilateral central scotoma associated with end-stage macular degeneration, defined as retinal findings of bilateral, geographic atrophy or disciform scar with foveal involvement.
- •Patients must have distance BCVA between 20/80 and 20/800, and adequate peripheral vision in one eye (the non-implanted eye) to allow navigation
- •Patients must achieve at least a five letter improvement on the ETDRS chart in the eye scheduled for surgery, with the external telescope simulator (ETS)
- •Patients must be available for the study duration of 12 months
- •Patients must be alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
- •Main Exclusion Criteria:
- •Evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months.
- •Patients who may require fellow eye cataract extraction and intraocular lens implantation during the 12 months following WA-NG telescope implantation. If fellow eye cataract extraction is anticipated, this procedure should be performed at least 30 days prior to enrollment in the clinical study.
- •Patients who have had or are expected to have ophthalmic related surgery within the 30 days preceding implantation of the device.
- •Patients who have undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes.
- •Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
结局指标
主要结局
Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)
时间窗: 12 months
Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )
Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)
时间窗: 12 months
Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam)
Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire
时间窗: 12 months
Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )
Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))
时间窗: 12 months
Number of Adverse events associated with the implant and use of the device will be evaluated.
时间窗: 12 months
Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)
时间窗: 12 months
Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )
次要结局
未报告次要终点