Meduri Alessandro, Oliverio Giovanni William, Trombetta Luigi, Giordano Marta, Inferrera Leandro, Trombetta Costantino John
Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy.
J Ophthalmol. 2021 Mar 24;2021:6639418. doi: 10.1155/2021/6639418. eCollection 2021.
To evaluate efficacy and safety of intravitreal dexamethasone 0.7 mg implant in treatment-naïve DME patients and to assess the utility of OCT structural biomarkers as predictors of functional response after treatment.
Thirty-nine eyes of 39 diabetic patients with center involving DME were enrolled. Best-corrected visual acuity (BCVA) and SS-OCT (DRI SS-OCT Triton, Topcon, Japan) to evaluate central retinal thickness (CRT), serous retinal detachment (SRD), intraretinal cysts (IRC), number of hyper-reflective spots (HRS), integrity of the ellipsoid zone (EZ), disorganization of the inner retinal layers (DRIL), vitreomacular adhesion (VMA), vitreomacular traction (VMT), and posterior vitreous detachment (PVD) were evaluated at baseline and at 3, 6, and 12 months after treatment. Multiple logistic analysis was performed to evaluate the possible OCT biomarker as predictive factors for final visual acuity improvement at the end of treatment.
At 12 months after treatment, the mean BCVA improved from 51.6 ± 17.5 to 56.9 ± 17.3 ETDRS letters (=0.03). Furthermore, there were statistically significant changes in CRT, IRC, HRS, and SRD. Nineteen patients presented a >10-letters improvement in BCVA; the presence of SRD at baseline was a predictor of good functional treatment response at 12 months (OR 2.1; 95% C.I. 1.2-4.9; =0.001) as well as the presence of EZ integrity preoperatively (OR 1.3; 95% C.I. 0.5-2.4; =0.001) and the absence of vitreoretinal interface alteration (OR 1.1; 95% C.I. 0.3-2.3; =0.02). No significant changes in the IOP and lens status were observed throughout the follow-up period.
This study empathized the importance of structural biomarkers as predictors of favorable response and confirmed the efficacy and safety of intravitreal dexamethasone implant in treatment-naïve DME patients showing a better functional response in the presence of SRD integrity of EZ and absence of vitreoretinal alterations.
评估玻璃体内注射0.7毫克地塞米松植入物治疗初治糖尿病性黄斑水肿（DME）患者的疗效和安全性，并评估光学相干断层扫描（OCT）结构生物标志物作为治疗后功能反应预测指标的效用。
纳入39例患有累及黄斑中心的DME糖尿病患者的39只眼。在基线以及治疗后3、6和12个月时，评估最佳矫正视力（BCVA）以及使用扫频光学相干断层扫描（DRI SS-OCT Triton，日本拓普康公司）评估中心视网膜厚度（CRT）、浆液性视网膜脱离（SRD）、视网膜内囊肿（IRC）、高反射点数量（HRS）、椭圆体带（EZ）的完整性、视网膜内层紊乱（DRIL）、玻璃体黄斑粘连（VMA）、玻璃体黄斑牵引（VMT）和玻璃体后脱离（PVD）。进行多因素逻辑分析以评估可能的OCT生物标志物作为治疗结束时最终视力改善的预测因素。
治疗12个月后，平均BCVA从51.6±17.5 ETDRS字母提高到56.9±17.3 ETDRS字母（=0.03）。此外，CRT、IRC、HRS和SRD有统计学上的显著变化。19例患者的BCVA提高了>10个字母；基线时存在SRD是12个月时良好功能治疗反应的预测指标（比值比2.1；95%置信区间1.2 - 4.9；=0.001），术前EZ完整性的存在（比值比1.3；95%置信区间0.5 - 2.4；=0.001）以及玻璃体视网膜界面无改变（比值比1.1；95%置信区间0.3 - 2.3；=0.02）也是预测指标。在整个随访期间，未观察到眼压和晶状体状态有显著变化。
本研究强调了结构生物标志物作为良好反应预测指标的重要性，并证实了玻璃体内注射地塞米松植入物治疗初治DME患者的疗效和安全性，在存在EZ的SRD完整性且无玻璃体视网膜改变的情况下显示出更好的功能反应。
