Purpose

Loss of photoreceptors in atrophic age-related macular degeneration results in severe visual impairment, although some peripheral vision is retained. To restore central vision without compromising the residual peripheral field, we developed a wireless photovoltaic retinal implant (PRIMA; Pixium Vision, Paris, France) in which pixels convert images projected from video glasses using near-infrared light into electric current to stimulate the nearby inner retinal neurons.

Design

We carried out a first-in-human clinical trial to test the safety and efficacy of the prosthesis in patients with geographic atrophy (ClinicalTrials.gov identifier, NCT03333954).

Participants

Five patients with geographic atrophy zone of at least 3 optic disc diameters, no foveal light perception, and best-corrected visual acuity of 20/400 to 20/1000 in the worse-seeing study eye.

Methods

The 2-mm wide, 30-μm thick chip, containing 378 pixels (each 100 μm in diameter), was implanted subretinally in the area of atrophy (absolute scotoma).

Main Outcome Measures

Anatomic outcomes were assessed with fundus photography and OCT for up to 12 months of follow-up. Prosthetic vision was assessed by mapping light perception, bar orientation, letter recognition, and Landolt C acuity.

Results

In all patients, the prosthesis was implanted successfully under the macula, although in 2 patients, it was implanted in unintended locations: within the choroid and off center by 2 mm. All 5 patients could perceive white-yellow prosthetic visual patterns with adjustable brightness in the previous scotomata. The 3 with optimal placement of the implant demonstrated prosthetic acuity of 20/460 to 20/550, and the patient with the off-center implant demonstrated 20/800 acuity. Residual natural acuity did not decrease after implantation in any patient.

Conclusions

Implantation of the PRIMA did not decrease the residual natural acuity, and it restored visual sensitivity in the former scotoma in each of the 5 patients. In 3 patients with the proper placement of the chip, prosthetic visual acuity was only 10% to 30% less than the level expected from the pixel pitch (20/420). Therefore, the use of optical or electronic magnification in the glasses as well as smaller pixels in future implants may improve visual acuity even further.

中文翻译：

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萎缩性年龄相关性黄斑变性中心视力的光伏恢复。

目的

萎缩性年龄相关性黄斑变性中光感受器的丧失会导致严重的视力障碍，但保留了一些周边视力。为了在不影响剩余周边视野的情况下恢复中心视力，我们开发了一种无线光伏视网膜植入物（PRIMA；Pixium Vision，法国巴黎），其中像素将使用近红外光从视频眼镜投影的图像转换为电流以刺激附近的内部视网膜神经元。

设计

我们进行了首次人体临床试验，以测试假体在地理萎缩患者中的安全性和有效性（ClinicalTrials.gov 标识符，NCT03333954）。

参与者

5 名具有至少 3 倍视盘直径的地理萎缩区、无中央凹光感且视力较差的研究眼的最佳矫正视力为 20/400 至 20/1000 的患者。

方法

2 毫米宽、30 微米厚的芯片，包含 378 个像素（每个直径 100 微米），植入视网膜下萎缩区域（绝对暗点）。

主要观察指标

在长达 12 个月的随访中，通过眼底照相和 OCT 评估解剖结果。通过映射光感、条形方向、字母识别和 Landolt C 敏锐度来评估假肢视力。

结果

在所有患者中，假体均成功植入黄斑下，但有 2 名患者植入了非预期位置：脉络膜内和偏离中心 2 毫米。所有 5 名患者都可以感知到先前暗点中亮度可调的白黄色假肢视觉图案。3 位植入物最佳放置的患者表现出 20/460 至 20/550 的修复视力，而使用偏心植入物的患者表现出 20/800 的视力。任何患者植入后残余自然视力均未降低。

结论

PRIMA 的植入没有降低残余自然视力，并且在 5 名患者中的每一个中恢复了前盲点的视觉敏感性。在正确放置芯片的 3 名患者中，假体视力仅比像素间距 (20/420) 的预期水平低 10% 至 30%。因此，在眼镜中使用光学或电子放大以及在未来植入物中使用更小的像素可能会进一步提高视力。