DEX combined PPV in PDR
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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.
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