Department of Ophthalmology, Eye and ENT Hospital, Fudan University, 83 Fenyang Road, Shanghai, 200031, China.
Shanghai Key Laboratory of Visual Impairment and Restoration, Shanghai, 200031, China.
BMC Ophthalmol. 2020 Feb 3;20(1):43. doi: 10.1186/s12886-020-1321-9.
To investigate the effect of intravitreal conbercept (IVC) injections on the incidence of postoperative vitreous hemorrhage (VH) in eyes undergoing surgery for severe proliferative diabetic retinopathy.
This was a pilot prospective, comparative, and randomized study. Thirty patients, who underwent vitrectomy for severe proliferative diabetic retinopathy, were assigned randomly to either group 1 (intravitreal conbercept [IVC] injection at the end of pars plana vitrectomy) or group 2 (no IVC injection). Postoperative follow-up was performed on the first day, first week, first month, third month, sixth month and first year after surgery. The primary outcome was the incidence of postoperative VH. Secondary outcomes were the initial time of vitreous clearing (ITVC), best-corrected visual acuity (BCVA) and central retinal thickness (CRT) after surgery.
A total of 30 eyes, from 30 patients, were included. Fifteen eyes were enrolled in the IVC group and fifteen in the control group. The incidence of early and late postoperative VH was not significantly different between the control and IVC groups. ITVC was shorter in the IVC group than that in the control group, but this was not significant (7.38 ± 10.66 vs 13.23 ± 17.35, P = 0.31). Final BCVA, 1 year after surgery, showed significant improvement compared to baseline in both groups. However, analysis of the BCVA at any postoperative visit after surgery showed no significant differences between the two groups. There were two cases of recurrent VH identified at 3 and 6 months after surgery in each group, requiring a second round of surgery. Foveal thickness was significantly different between the two groups at the 3-month, 6-month and 1-year follow-up visits.
In this pilot study, the effect of IVC injection in reducing the incidence of postoperative VH after diabetic vitrectomy at the end of vitrectomy was not shown.
The study was registered with the Chinese Clinical Trial Registry. (Reference Number: ChiCTR1800015751).
研究目的为探讨玻璃体内注射康柏西普(conbercept，IVC)对玻璃体切割术治疗严重增殖性糖尿病视网膜病变后玻璃体积血（VH）发生率的影响。
本研究为前瞻性、对照和随机研究。30 例（30 只眼）接受玻璃体切割术治疗严重增殖性糖尿病视网膜病变的患者，随机分为 1 组（玻璃体切割术结束时玻璃体内注射康柏西普）或 2 组（不注射）。术后第 1 天、第 1 周、第 1 个月、第 3 个月、第 6 个月和第 1 年进行随访。主要结局是术后 VH 的发生率。次要结局是术后初始玻璃体清晰度（ITVC）、最佳矫正视力（BCVA）和术后中央视网膜厚度（CRT）。
共纳入 30 只眼，其中 15 只眼纳入 IVC 组，15 只眼纳入对照组。两组术后早期和晚期 VH 的发生率无统计学差异。IVC 组 ITVC 短于对照组，但无统计学意义（7.38 ± 10.66 比 13.23 ± 17.35，P = 0.31）。两组术后 1 年 BCVA 均较基线显著提高，但术后任何随访时间的 BCVA 分析两组间无显著差异。两组各有 2 例术后 3 个月和 6 个月分别出现复发性 VH，需再次手术。两组在术后 3 个月、6 个月和 1 年随访时的黄斑厚度均有显著差异。
本研究未显示玻璃体切割术结束时玻璃体腔内注射康柏西普对糖尿病玻璃体切割术后 VH 发生率的降低作用。
本研究在中国临床试验注册中心注册（注册号：ChiCTR1800015751）。
