METHODS: Retrospective, multicenter study. The number of HRDs was graded in four different stages: [A] none HRDs; [B] few, 1-10 HRDs; [C] moderate, 11-20 HRDs; and [D] many, ≥ 21 HRDs. For statistical purposes, groups A and B were combined [scarce HRDs (S-HRDs)] and group D was renamed as [abundant HRDs (A-HRDs)]. The primary endpoints were the mean change in best corrected visual acuity (BCVA) and central macular thickness (CMT) according to baseline HRD stage.
RESULTS: One hundred eyes from one hundred patients were included in the study. Mean BCVA significantly improved from 52.9 (50.0 to 55.8) letters ETDRS at baseline to 57.2 (54.0 to 60.4) letters at month 6, p = 0.0039. There were no significant differences between the S-HRDs and A-HRD study groups in BCVA. As compared to baseline, CMT reduction was 106.3 (59.8 to 152.7) μm and 94.2 (34.7 to 153.7) μm in S-HRDs and A-HRD groups, respectively (p < 0.0001 each, respectively). Twenty-three (65.7%) and 18 (62.1%) eyes achieved a CMT reduction ≥ 10% in the S-HRD and A-HRD groups, respectively, p = 0.7640. DEX implant significantly reduced the presence of outer nuclear layer (ONL) disruptions (p = 0.0010).
CONCLUSIONS: The number of HRDs did not influence either functional or anatomic outcomes. DEX implant significantly decreases the number of eyes with ONL disruptions, which might improve retinal integrity.
方法:回顾性,多中心研究。HRD的数量分为四个不同的阶段:[A]无HRD;[B]很少,1-10个HRDs;[C]中等,11-20个HRDs;和[D]许多,≥21HRDs。出于统计目的,A组和B组合并[稀缺HRDs(S-HRDs)],D组更名为[丰富HRDs(A-HRDs)]。主要终点是根据基线HRD阶段的最佳矫正视力(BCVA)和中央黄斑厚度(CMT)的平均变化。
结果:本研究纳入了100名患者的100只眼。平均BCVA从基线时的52.9(50.0至55.8)个字母ETDRS显著改善至第6个月时的57.2(54.0至60.4)个字母,p=0.0039。在BCVA中,S-HRD和A-HRD研究组之间没有显着差异。与基线相比,在S-HRDs和A-HRD组中,CMT降低为106.3(59.8至152.7)μm和94.2(34.7至153.7)μm,分别(每个p<0.0001,分别)。在S-HRD和A-HRD组中,23只(65.7%)和18只(62.1%)眼实现了CMT降低≥10%,分别,p=0.7640。DEX植入物显著减少了外核层(ONL)破坏的存在(p=0.0010)。
结论:HRDs的数量不影响功能或解剖结果。DEX植入物显着减少了ONL中断的眼睛数量,这可能会改善视网膜的完整性。