Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Atrophic Dry Age Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Near Visual Acuity
研究概览
简要总结
In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA is tested in five subjects suffering from atrophic dry age related macular degeneration.
详细描述
PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual perception in patients with vision loss from atrophic dry Age-related Macular Degeneration. The implantable part of the device is placed under the retina. A mini camera mounted on a pair of glasses captures the visual scene in the environment. The visual scene is processed and simplified by the pocket computer connected to the glasses in order to extract useful information from the images. The simplified images are then sent back to the glasses where a miniaturized projector then projects the processed images wirelessly via pulses of near infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic cells convert this optical information into electrical stimulation to excite the nerve cells of the retina and induce visual perception. In this early feasibility study five human subjects suffering from atrophic dry age related macular degeneration will receive the implant. The performance and the safety of the device will be monitored for up to 36 months.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is 60 years or older at the date of inclusion;
- •Has a confirmed diagnosis of atrophic dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters in the study eye;
- •Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in the study eye measured by ETDRS;
- •Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale in the visual field covering the central 7 degrees (+/-3.5 degrees) and maximum 20% perception in the remaining visual field covering the central 12 degrees (+/- 6 degrees);
- •Meets one of the following criteria in the non-study eye:
- •Visual acuity of 20/200 (logMAR 1.0) or worse and an atrophy size <8mm2
- •Visual acuity of 20/160 (logMAR 0.9) or worse and an atrophy size ≥8mm2 and ≤12.5 mm2
- •Visual acuity of 20/100 (logMAR 0.7) or worse and an atrophy size >12.5 mm2
- •Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);
- •Understands and accepts the obligation to present for all schedule follow-up visits;
- •Patient signed informed consent.
排除标准
- •Has cataract in the study ;
- •Has an aphakic study eye;
- •Has no light perception in the study eye;
- •Has a history of choroidal neovascularization in either eye;
- •Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye
- •Has an implanted telescope in one eye;
- •Has any disease or condition that prevents adequate examination of the study
- •Has a corneal endothelial cell count of less than 1000 cells/mm² in the study eye
- •Suffers from nystagmus or other ocular motility disorders;
- •Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols
- •Has a history of epileptic seizure;
- •Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
- •Presents with hypotony or hypertony in the study eye;
- •Has another active implanted device;
- •Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis;
- •Is an immune-suppressed subject;
- •Is carrier of multi-resistant microorganisms;
- •Is receiving anticoagulation therapy that cannot be adapted to allow eye surgery;
- •Is participating in another investigational drug or device study that may interfere with the present study;
- •Has recurrent or chronic inflammations or infections;
- •Has a severe psychological disorder;
- •Does not have the mental capacity to legally sign the informed consent;
- •Has severe renal, cardiac, hepatic, etc. organ diseases;
- •Has head dimensions that are incompatible with the Visual Interface;
- •Has too high and unrealistic expectation;
- •Detailed patient criteria will be verified by the study doctor.
研究组 & 干预措施
PRIMA
Implantation of PRIMA device
干预措施: PRIMA (Device)
结局指标
主要结局
Near Visual Acuity
时间窗: 12 months after implantation
Near Visual acuity measured by FrACT
次要结局
- Quality of Life(12, 24, and 36 months after implantation)
- Reading Acuity Test(6, 12, 24, 36 months after implantation)
- Near Visual Acuity(3, 6, 9, 18, 24, and 36 months after implantation)
- Visual Acuity(3, 6, 9, 12, 18, 24 and 36 months after implantation)
- Quality of Life Questionnaire(12, 24, and 36 months after implantation)