Department of Ophthalmology, Stony Brook University Hospital, Stony Brook, NY, 11790, USA.
BMC Ophthalmol. 2023 Feb 16;23(1):70. doi: 10.1186/s12886-022-02736-w.
The Argus II Retinal Prosthesis System (Second Sight Medical Products, Sylmar, California) is an epiretinal prosthesis that serves to provide useful vision to people who are affected by retinal degenerative diseases such as retinitis pigmentosa (RP). The purpose of this study was to analyze postoperative movement of the electrode array.
Five patients diagnosed with profound retinal dystrophy who have undergone implantation of retinal prosthesis at Stony Brook University Hospital. Fundoscopy was performed at postoperative month 1 (M1), month 3 (M3), month 6 (M6), month 12 (M12), and month 24 (M24) visits. Fundoscopy was extracted and analyzed via NIH ImageJ. Data analysis was completed using IBM SPSS. Various lengths and angles were measured each postoperative month using ImageJ.
There was no significant change in distance between the optic disc and the surgical handle (length AB) over the two-year span (F = 0.196, p = 0.705). There was a significant change in distance of length AB over time between patients between M3 and M6 (p = 0.025). A repeated measures ANOVA revealed that there was statistically significant change of the optic disc-tack-surgical handle angle (𝛾) (M1 to M24) (F = 3.527, p = 0.030). There was no significant change in angle 𝜟 (the angle to the horizontal of the image), angle 𝜶 (tack-optic disc-surgical handle), and angle 𝜷 (optic-disc-surgical handle-tack).
Our results demonstrate that there may be postoperative movement of the retinal prosthesis over time, as a statistically significant downward rotation is reported over the 2 years span. It is important, moving forward, to further study this movement and to take into consideration such movement when designing retinal implants. It is important to note that this study is limited by the small sample size, and therefore, the conclusions drawn are limited.
Argus II 视网膜假体系统（Second Sight Medical Products，加利福尼亚州 Sylmar）是一种眼内视网膜假体，用于为受视网膜退行性疾病（如色素性视网膜炎（RP））影响的人提供有用的视力。本研究的目的是分析术后电极阵列的运动。
在 Stony Brook 大学医院接受视网膜假体植入的 5 名被诊断为严重视网膜营养不良的患者。术后第 1 个月（M1）、第 3 个月（M3）、第 6 个月（M6）、第 12 个月（M12）和第 24 个月（M24）进行眼底检查。使用 NIH ImageJ 提取和分析眼底照片。使用 IBM SPSS 完成数据分析。使用 ImageJ 每月测量各种长度和角度。
在两年的时间内，视盘和手术手柄之间的距离（AB 长度）没有明显变化（F=0.196，p=0.705）。在 M3 和 M6 之间，患者之间 AB 长度的距离在时间上有显著变化（p=0.025）。重复测量方差分析显示，视盘-靶-手术手柄角度（γ）（M1 至 M24）有统计学显著变化（F=3.527，p=0.030）。角度β（图像的水平角）、角度α（靶-视盘-手术手柄）和角度δ（视盘-手术手柄-靶）没有明显变化。
我们的结果表明，随着时间的推移，视网膜假体可能会发生术后运动，因为报告了在 2 年的时间内有统计学上显著的向下旋转。在设计视网膜植入物时，进一步研究这种运动并考虑到这种运动非常重要。需要注意的是，本研究受到样本量小的限制，因此得出的结论也有限。
