背景:我们旨在研究光学相干断层扫描(OCT)的解剖学特征和玻璃体细胞因子水平作为特发性视网膜前膜(iERM)治疗的玻璃体玻璃体切除术联合玻璃体内地塞米松(DEX)植入物的预后预测因子。
方法:前瞻性,单面具,随机化,对照临床试验包括48只眼。他们以1:1的比例随机分配到DEX组(联合晶状体玻璃体切除术与ERM剥离和Ozurdex植入)和对照组(仅晶状体玻璃体切除术)。在1d时评估最佳矫正视力(BCVA)和中央黄斑厚度(CMT)。1周,1个月,和3个月。对术前OCT的结构特征进行分层分析。使用ELISA测量玻璃体液中的基线可溶性CD14(sCD14)和sCD163水平。
结果:BCVA和CMT在DEX组和对照组中没有显着差异。基线时具有高反射焦点(HRF)的眼睛在随访期间获得了较好的BCVA(Ptime*组=0.746;P组=0.043,Waldχ²=7.869)和较低的CMT(Ptime*组=0.079;P组=0.001,Waldχ²=6.774)对DEX的反应。在所有患者中,基线时HRF眼sCD163的平均玻璃体水平显著高于无HRF眼(P=0.036,Z=-2.093)。在DEX组中,较高的sCD163预测CMT从基线至1个月的下降幅度更大(r=0.470,P=0.049).
结论:我们发现,在所有iERM患者中,术中DEX植入在3个月内对BCVA和CMT均无有益影响,暗示不建议对所有iERM使用DEX。相比之下,对于在OCT上有HRF的患者,在3个月随访时对DEX植入物的反应更好,而在基线时,其玻璃体液中sCD163的表达水平更高.这些数据支持以下假设:DEX植入物在治疗ERM继发于炎症的病例中可能特别有效。
背景:该试验已在中国临床试验注册中心注册(https://www.chictr.org.cn)2021/03/12(ChiCTR2100044228)。文章中的所有患者均在注册后入组。
BACKGROUND: We aimed to investigate the anatomical features of optical coherence tomography (OCT) and vitreous cytokine levels as predictors of outcomes of combined phacovitrectomy with intravitreal dexamethasone (DEX) implants for idiopathic epiretinal membrane (iERM) treatment.
METHODS: A prospective, single-masked, randomized, controlled clinical trial included 48 eyes. They were randomly assigned in a 1:1 ratio to undergo the DEX group (combined phacovitrectomy with ERM peeling and Ozurdex implantation) and control group (phacovitrectomy only). Best-corrected visual acuity (BCVA) and central macular thickness (CMT) were assessed at 1 d, 1 week, 1 month, and 3 months. The structural features of OCT before surgery were analysed for stratified analysis. Baseline soluble CD14 (sCD14) and sCD163 levels in the vitreous fluid were measured using ELISA.
RESULTS: BCVA and CMT were not significantly different in the DEX and control groups. Eyes with hyperreflective foci (HRF) at baseline achieved better BCVA (Ptime*group=0.746; Pgroup=0.043, Wald χ²=7.869) and lower CMT (Ptime*group = 0.079; Pgroup = 0.001, Wald χ²=6.774) responses to DEX during follow-up. In all patients, the mean vitreous level of sCD163 in eyes with HRF was significantly higher than that in eyes without HRF (P = 0.036, Z=-2.093) at baseline. In the DEX group, higher sCD163 predicted greater reduction in CMT from baseline to 1 month (r = 0.470, P = 0.049).
CONCLUSIONS: We found that intraoperative DEX implantation did not have beneficial effects on BCVA and CMT over a 3-month period in all patients with iERM, implying that the use of DEX for all iERM is not recommended. In contrast, for those with HRF on OCT responded better to DEX implants at the 3-month follow-up and thier vitreous fluid expressed higher levels of sCD163 at baseline. These data support the hypothesis that DEX implants may be particularly effective in treating cases where ERM is secondary to inflammation.
BACKGROUND: The trail has been registered at Chinese Clinical Trail Registry( https://www.chictr.org.cn ) on 2021/03/12 (ChiCTR2100044228). And all patients in the article were enrolled after registration.