DEX combined PPV in PDR

Purpose To evaluate the efficacy and safety of adjunctive intraoperative dexamethasone implant (DEX) during pars plana vitrectomy (PPV) with meticulous posterior vitreous cortex (PVC) removal in advanced proliferative diabetic retinopathy (PDR).
Methods In this prospective, single-center, single-masked randomized controlled trial, 104 eyes with advanced PDR were randomized (1:1) to PPV with DEX (n=50) or PPV alone (n=54). All procedures followed a standardized protocol with triamcinolone-assisted complete PVC removal and sequential verification. The primary outcome was the proportion of eyes achieving ≥15-letter best-corrected visual acuity (BCVA) improvement at 6 months. Longitudinal BCVA and central foveal thickness (CFT) were analyzed using linear mixed-effects models. Prespecified interaction analyses across 15 baseline variables were exploratory and not adjusted for multiplicity.
Results At 6 months, ≥15-letter improvement was achieved in 74.0% of eyes in the DEX group and 70.4% in controls (OR, 1.20; 95% CI, 0.51–2.83; P=0.680). Mean BCVA gain was comparable between groups (+37.6 vs +35.3 letters; P=0.912), with no significant treatment-by-time interaction for BCVA (P=0.973) or CFT (P=0.326). Although the DEX group showed a numerically thinner CFT at month 1, this difference was not statistically significant and was not sustained thereafter. Postoperative epiretinal membrane formation was <1% in both groups. Intraocular pressure elevation occurred more frequently in the DEX group (26.0% vs 9.3%; P=0.037; number needed to harm = 6), and 10.0% of DEX-treated eyes versus 1.9% of controls required glaucoma surgery.
Conclusion Adjunctive intraoperative DEX did not improve visual or sustained anatomical outcomes following meticulous PPV with complete PVC removal in advanced PDR. Its use was associated with an increased risk of intraocular pressure elevation and glaucoma surgery. These findings do not support routine use of DEX in this surgical setting, while underscoring the importance of thorough PVC removal in surgical management.

研究目的：评估在晚期增生性糖尿病视网膜病变（proliferative diabetic retinopathy, PDR）患者中，行精细后玻璃体皮质（posterior vitreous cortex, PVC）剥离的经睫状体平坦部玻璃体切割术（pars plana vitrectomy, PPV）时，术中辅助应用地塞米松植入剂（dexamethasone implant, DEX）的有效性与安全性。
研究方法：本研究为一项前瞻性、单中心、单盲随机对照试验，共纳入104只确诊晚期PDR的患眼，按1:1比例随机分为PPV联合DEX组（n=50）与单纯PPV组（n=54）。所有手术均遵循标准化方案，采用曲安奈德辅助完成完全性PVC剥离并进行顺序验证。主要结局指标为术后6个月时最佳矫正视力（best-corrected visual acuity, BCVA）提升≥15个字母的患眼占比。采用线性混合效应模型（linear mixed-effects models）分析纵向BCVA与中心凹厚度（central foveal thickness, CFT）的变化情况。预设的15项基线变量间交互分析为探索性分析，未进行多重比较校正。
研究结果：术后6个月时，DEX组74.0%的患眼实现BCVA提升≥15个字母，对照组为70.4%（优势比[OR]=1.20；95%置信区间[CI]：0.51~2.83；P=0.680）。两组患者的平均BCVA提升量相当（+37.6 vs +35.3个字母；P=0.912），BCVA与CFT均未出现显著的治疗-时间交互效应（分别为P=0.973、P=0.326）。尽管DEX组在术后1个月时的CFT数值更低，但该差异无统计学意义，且后续未持续存在。两组术后视网膜前膜形成率均<1%。DEX组的眼压升高发生率更高（26.0% vs 9.3%；P=0.037；需伤害病例数=6），且DEX组有10.0%的患眼需行青光眼手术，对照组仅为1.9%。
研究结论：对于晚期PDR患者行精细完全性PVC剥离的PPV术后，术中辅助使用DEX并未改善患者的视力或持续解剖学结局。其使用与眼压升高及青光眼手术风险增加相关。本研究结果不支持在该手术场景中常规使用DEX，同时强调了彻底PVC剥离在手术治疗中的重要性。