Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, 11794, USA.
BMC Ophthalmol. 2020 Sep 17;20(1):366. doi: 10.1186/s12886-020-01631-6.
Post-implantation visual outcomes in patients with the Argus II Retinal Prosthesis is dependent on a multitude of factors including the positioning of the electrode array on the retina. The purpose of this study is to determine whether the average electrode array-retina gap distance correlates with objective visual function outcomes and sensitivity detection thresholds in patients implanted with the Argus II Retinal Prosthesis.
Five patients with implantation of the Argus II Retinal Prosthesis were enrolled in this single-institution retrospective study. Patient demographics were collected from medical records. Visual function data (Square Localization [SL] and Direction of Motion [DOM]) and Optical Coherence Tomography (Cirrus HD-OCT) images were extracted retrospectively from the Argus II Retinal Prosthesis Post-Approval study. Visual function tests were performed with the device OFF and ON at each study visit. Electrode array-retina gap distances were measured at each of the array's 60 electrodes using the Cirrus HD-OCT software in both the nasotemporal and superoinferior planes. Data was obtained at baseline, and post-operative month 1, month 3, month 6, and year 1. Sensitivity detection thresholds were obtained at the initial programming visit and each reprogramming session.
Three patients performed significantly better in SL visual function testing with the device ON. Patients that worsened in visual function testing with the device ON in both SL and DOM testing had a statistically significant decrease in performance. The electrode array-retina gap distance was found to effect performance in SL testing in a patient-dependent manner. No effect was found between the electrode-array gap distance and DOM testing or sensitivity detection threshold.
Our results demonstrate that the electrode array-retina gap distance may affect visual function outcomes in SL testing in certain patients with the Argus II Retinal Prosthesis, and the direction and magnitude of this effect is likely patient-dependent. Furthermore, complete apposition between the electrode array and retina may not always be necessary to achieve optimal visual outcomes.
植入 Argus II 视网膜假体后的视觉效果取决于多种因素，包括视网膜上电极阵列的位置。本研究的目的是确定 Argus II 视网膜假体植入患者的平均电极阵列-视网膜间隙距离是否与客观视觉功能结果和敏感度检测阈值相关。
本研究为单中心回顾性研究，纳入了 5 名植入 Argus II 视网膜假体的患者。从病历中收集患者的人口统计学资料。回顾性地从 Argus II 视网膜假体批准后研究中提取视觉功能数据（方形定位 [SL] 和运动方向 [DOM]）和光学相干断层扫描（Cirrus HD-OCT）图像。在每次研究访视时，使用设备 OFF 和 ON 进行视觉功能测试。在 Cirrus HD-OCT 软件中，在鼻颞和上下平面上测量每个阵列的 60 个电极的电极阵列-视网膜间隙距离。在基线、术后第 1、3、6 个月和第 1 年获得数据。在初始编程访问和每次重新编程会话时获得敏感度检测阈值。
3 名患者在设备 ON 时 SL 视觉功能测试中表现明显更好。在 SL 和 DOM 测试中，设备 ON 时视觉功能测试恶化的患者，其表现有统计学显著下降。电极阵列-视网膜间隙距离发现以患者依赖的方式影响 SL 测试中的性能。在 DOM 测试或敏感度检测阈值之间未发现电极-阵列间隙距离的影响。
我们的结果表明，在 Argus II 视网膜假体的某些患者中，电极阵列-视网膜间隙距离可能会影响 SL 测试中的视觉功能结果，并且这种影响的方向和幅度可能取决于患者。此外，电极阵列和视网膜之间完全贴合不一定总是需要达到最佳的视觉结果。
