Department of Ophthalmology, Peking University People's Hospital, Beijing, China.
Department of Ophthalmology, Xiamen Eye Center of Xiamen University, Xiamen, China.
Front Public Health. 2023 Jan 11;10:1067670. doi: 10.3389/fpubh.2022.1067670. eCollection 2022.
The aim of this study was to assess the effects of preoperative intravitreal aflibercept (IVA) injection on the incidence of postoperative vitreous hemorrhage (VH) after vitrectomy for proliferative diabetic retinopathy (PDR).
This study involved a prospective, randomized clinical trial. One hundred twenty-eight eyes of 128 patients of PDR who underwent pars plana vitrectomy (PPV) were enrolled. Sixty-four eyes were assigned randomly to either the IVA group (IVA injection 1 to 5 days before PPV) or the control group (no IVA injection). The primary outcome was the incidence of VH at 1 month after PPV. Secondary outcome measures were best-corrected visual acuity (BCVA) changes from baseline to at 1 week, 1 month, 2 months, and 3 months after surgery.
The VH incidences in the IVA group and the control group were 14.8 and 39.3% at week 1, 8.6 and 31.7% at month 1, 11.7 and 30.5% at month 2, and 8.6 and 30.5% at month 3, respectively. Intergroup differences showed a significantly decreased VH rate in the IVA group compared with that in the control group at week 1, month 1, and month 3 ( = 0.021, 0.006, and 0.047, respectively). Compared to the baseline, neither the mean BCVA nor the BCVA change in the Logarithm of the Minimum Angle of Resolution (logMAR) scale did differ significantly between the two groups at each visit point. There are a greater number of eyes with BCVA improvement of more than 2 logMAR in the IVA group than in the control group at week 1 (8 vs. 2, = 0.048).
This study found that the adjunctive use of preoperative IVA reduces early and late postoperative VH in vitrectomy for PDR.
本研究旨在评估术前玻璃体内注射阿柏西普(IVA)对增生型糖尿病视网膜病变(PDR)患者玻璃体切割术后玻璃体积血(VH)发生率的影响。
本研究为前瞻性、随机临床试验。纳入 128 例 PDR 患者的 128 只眼,均接受经睫状体平坦部玻璃体切除术(PPV)。将 64 只眼随机分为 IVA 组(PPV 前 1 至 5 天给予 IVA 注射)和对照组(不给予 IVA 注射)。主要结局为 PPV 后 1 个月 VH 的发生率。次要结局测量为从基线到术后 1 周、1 个月、2 个月和 3 个月时最佳矫正视力(BCVA)的变化。
IVA 组和对照组在第 1 周、第 1 个月、第 2 个月和第 3 个月的 VH 发生率分别为 14.8%和 39.3%、8.6%和 31.7%、11.7%和 30.5%、8.6%和 30.5%。组间差异显示,IVA 组 VH 发生率在第 1 周、第 1 个月和第 3 个月时显著低于对照组( = 0.021、0.006 和 0.047)。与基线相比,两组在每个随访点的平均 BCVA 或 LogMAR 尺度上的 BCVA 变化均无显著差异。在第 1 周,IVA 组中有更多的眼睛 BCVA 改善超过 2 LogMAR,与对照组相比(8 对 2, = 0.048)。
本研究发现,术前 IVA 的辅助应用可减少 PDR 玻璃体切割术后早期和晚期的术后 VH。