Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study.

Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study.
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DOI:
10.1016/j.ajo.2018.06.012
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发表时间:
2018-09
影响因子:
4.2
通讯作者:
Zacks DN
Zacks DN
中科院分区:
医学1区
文献类型:
--
作者:
Gregori NZ;Callaway NF;Hoeppner C;Yuan A;Rachitskaya A;Feuer W;Ameri H;Arevalo JF;Augustin AJ;Birch DG;Dagnelie G;Grisanti S;Davis JL;Hahn P;Handa JT;Ho AC;Huang SS;Humayun MS;Iezzi R Jr;Jayasundera KT;Kokame GT;Lam BL;Lim JI;Mandava N;Montezuma SR;Olmos de Koo L;Szurman P;Vajzovic L;Wiedemann P;Weiland J;Yan J;Zacks DN

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评估Argus II型视网膜假体受者的视网膜解剖结构和排列位置。前瞻性、非比较队列研究设置:国际多中心研究患者:纳入上市后监测研究的Argus II受者。程序:审查为监测研究(NCT01860092和NCT01490827)收集的光谱域光学相干断层扫描图像。在1、3、6和12个月时记录基线和术后黄斑厚度、电极-视网膜距离(间隙)、视盘阵列重叠和视网膜前膜的存在。主要观察指标:视网膜轴向厚度和沿阵列长轴(大头钉和把手之间的一条线)的轴向间隙,最大视网膜厚度和最大间隙沿大头钉、中线和把手附近的b线扫描。来自美国和德国16个手术地点的33名患者被纳入研究。从第1个月到第12个月,每个位置的平均轴向视网膜厚度均有所增加,但仅在阵列中线处达到统计学意义(p值=0.007)。相对于坐具(坡度=3.60,p<0.001)和手柄(坡度=1.93,p=0.368),在阵列中线附近(坡度=6.02,p=0.004)的最大增厚率最高。平均轴向间隙和最大间隙在研究期间减小,平均最大间隙在中线处减小显著(p=0.032)。视盘排列重叠见于少数患者。植入前后视网膜前膜普遍存在。在阵列下进行性黄斑增厚是常见的,并且随着时间的推移对应于电极-视网膜间隙的减少。到第12个月,该阵列在大约一半的眼睛中完全与黄斑相对。
To assess the retinal anatomy and array position in the Argus II Retinal Prosthesis recipients. Prospective, non-comparative cohort study Setting: international multicenter study Patients: Argus II recipients enrolled in the Post-Market Surveillance Studies. Procedures: Spectral-domain Optical Coherence Tomography images collected for the Surveillance Studies (NCT01860092 and NCT01490827) were reviewed. Baseline and postoperative macular thickness, electrode-retina distance (gap), optic disc-array overlap, and preretinal membrane presence were recorded at 1, 3, 6, and 12 months. Main Outcome Measures: Axial retinal thickness and axial gap along the array’s long axis (a line between the tack and handle), maximal retinal thickness and maximal gap along a B-scan near the tack, midline, and handle. Thirty-three patients from 16 surgical sites in the United States and Germany were included. Mean axial retinal thickness increased from month 1 through month 12 at each location, but reached statistical significance only at the array midline (p- value=0.007). The rate of maximal thickness increase was highest near the array midline (slope=6.02, p=0.004), compared to the tack (slope=3.60, p<0.001) or the handle (slope=1.93, p=0.368). The mean axial and maximal gaps decreased over the study period, and the mean maximal gap size decrease was significant at midline (p=0.032). Optic disc-array overlap was seen in the minority of patients. Preretinal membranes were common before and after implantation. Progressive macular thickening under the array was common and corresponded to decreased electrode-retina gap over time. By month 12, the array was completely apposed to the macula in approximately half of the eyes.
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