Fouad Aziz Joseph Hany, Abd Al-Hakim Zaki Mohamed, Abd El-Fattah El-Shazly Amany, Mamoun Tarek, Abdel Ghaffar Helmy Reem Osama, Hashem Mohamed Hanafy
Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Med Hypothesis Discov Innov Ophthalmol. 2022 Dec 3;11(3):95-103. doi: 10.51329/mehdiophthal1452. eCollection 2022 Fall.
Proliferative vitreoretinopathy (PVR) is the leading cause of recurrent retinal detachment after surgical repair of rhegmatogenous retinal detachment (RRD). Our study aimed to assess the efficacy and safety of intravitreal methotrexate infusion (IMI) for the prevention of PVR after pars plana vitrectomy (PPV) in eyes with RRD.
This prospective comparative interventional study was conducted from September 2020 to November 2021 at Ain Shams University Hospitals, Egypt. We recruited a consecutive, non-randomized sample of 47 eyes of 47 patients with RRD undergoing PPV. Participants were allocated to a control group or an intervention group that received IMI during surgery. Each group was subdivided into subgroups of eyes at high-risk of developing PVR and eyes with established preoperative PVR grade C. Outcome measures at the 3-month postoperative follow-up were the rate of retinal attachment, incidence of PVR, reoperation rate to flatten the retina, and changes in the retina and/or optic nerve function as assessed by full-field electroretinogram and flash visual evoked potential.
Data from 47 eyes (23 and 24 eyes in the intervention and control groups, respectively) were evaluated. Subgroups IA, IB, and IIB each included 12 eyes, subgroup IIA included 11 eyes, and all subgroups had comparable sex ratios and age distributions. Postoperative PVR at 1 month and between 1 and 3 months was present in 13% and 4% of eyes in the intervention group, respectively. Reoperation to flatten the retina was required in 2 (9%) eyes in the intervention group, while 22 eyes (96%) had complete flattening of the retina at 3 months. No significant differences were found between the study groups and the corresponding subgroups regarding the outcome measures (all > 0.05). No adverse events attributable to IMI were detected up to 3 months postoperatively.
Although IMI was safe for intraocular use in eyes with RRD and PVR grade C or a high risk of developing PVR, it did not affect the anatomical success rate or development of PVR up to 3 months after PPV. Further multicenter randomized clinical trials with longer follow-up periods and larger sample sizes are needed to verify these preliminary outcomes.
增殖性玻璃体视网膜病变(PVR)是孔源性视网膜脱离(RRD)手术修复后视网膜反复脱离的主要原因。我们的研究旨在评估玻璃体内注射甲氨蝶呤(IMI)预防RRD患者行玻璃体切割术(PPV)后发生PVR的有效性和安全性。
这项前瞻性对比干预研究于2020年9月至2021年11月在埃及艾因夏姆斯大学医院进行。我们连续纳入了47例接受PPV的RRD患者的47只眼,非随机分组。参与者被分配到对照组或手术期间接受IMI的干预组。每组又分为发生PVR高危眼亚组和术前已确诊PVR C级的眼亚组。术后3个月随访的观察指标包括视网膜附着率、PVR发生率、视网膜复位再手术率,以及通过全视野视网膜电图和闪光视觉诱发电位评估的视网膜和/或视神经功能变化。
对47只眼(干预组23只眼,对照组24只眼)的数据进行了评估。IA、IB和IIB亚组各有12只眼,IIA亚组有11只眼,所有亚组的性别比例和年龄分布具有可比性。干预组1个月时和1至3个月时的术后PVR分别出现在13%和4%的眼中。干预组有2只眼(9%)需要进行视网膜复位再手术,而22只眼(96%)在3个月时视网膜完全复位。研究组与相应亚组在观察指标方面未发现显著差异(均P>0.05)。术后3个月内未检测到与IMI相关的不良事件。
尽管IMI在RRD合并PVR C级或发生PVR高危眼内眼使用是安全的,但在PPV后3个月内它并未影响解剖学成功率或PVR的发生发展。需要进一步开展多中心、随访期更长、样本量更大的随机临床试验来验证这些初步结果。