Nasr Mohamed, Abdelhadi Ahmed, Bessa Amr, Ibrahim Tamer Moussa
Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.
BMC Ophthalmol. 2024 Mar 4;24(1):97. doi: 10.1186/s12886-024-03362-4.
Pediatric rhegmatogenous retinal detachments (PRRDs) are complex, rare occurrences and are often related to trauma or congenital abnormalities. Children often do not recognize or report symptoms of retinal detachment. Thus at presentation, PRRD is typically advanced often with macular involvement, proliferative vitreoretinopathy (PVR), chronic duration, and poor visual acuity. Because 5-FU and LMWH are effective in different aspects in the PVR process, it was believed that a syngergistic approach to the prevention of PVR would be advantageous.
After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml), group B received infusion of normal saline. Primary outcome was occurrence of recurrent PRRD within 12 weeks, secondary outcomes were occurrence of PVR, best corrected visual acuity (BCVA), number and timing of secondary procedures within 12 weeks.
The study included 42 eyes of 41 patients, 21 in group A and 21 in group B, the duration of PRRD ranged from 0.5 to 7 months in group A and 0.25-5 months in group B.The rate of recurrent PRRD was higher in group B 33% compared to 19% in group A (p = 0.292). The mean timing of occurrence of recurrent PRRD was 9.5 ± 5 weeks in group A compared to 2.86 ± 2.41 weeks in group B (p = 0.042), more patients in group B ended up with more advanced PVR (p = 0.038), BCVA was hand movement (HM) only in all cases preoperatively and improved to HM-0.3 Snellen in group A compared to light perception (PL)-0.1Snellen in group B (p = 0.035), there was no difference in any of secondary procedures but with later timing in group A 9.71 ± 3.73 weeks than in group B 4.0 ± 2.83 weeks (p = 0.042).
This study concluded that the use of the 5-FU and LMWH combination in high risk PRRD resulted in lower rate of postoperative PVR, later recurrence of PRRD and better final BCVA.
Registry: clinicaltrials.gov PRS NCT06166914 date of initial release 4/12/2023. Unique Protocol ID: 9,163,209 date 21/10/2021. Retrospectively registered.
小儿孔源性视网膜脱离（PRRD）情况复杂且罕见，常与外伤或先天性异常有关。儿童往往无法识别或报告视网膜脱离症状。因此，在就诊时，PRRD通常已发展到晚期，常累及黄斑，伴有增殖性玻璃体视网膜病变（PVR）、病程较长且视力较差。由于5-氟尿嘧啶（5-FU）和低分子量肝素（LMWH）在PVR过程的不同方面有效，因此认为采用协同方法预防PVR将具有优势。
在获得知情同意后，对14岁以下患有高危PRRD的儿童进行前瞻性随机试验，行玻璃体切割联合巩膜扣带术及硅油注入术，并分为两组。A组术中输注5-FU（200μg/ml）和LMWH（5IU/ml），B组输注生理盐水。主要结局是12周内复发性PRRD的发生情况，次要结局包括PVR的发生情况、最佳矫正视力（BCVA）、12周内二次手术的次数和时间。
该研究纳入了41例患者的42只眼，A组21只眼，B组21只眼。A组PRRD病程为0.5至7个月，B组为0.25至5个月。B组复发性PRRD的发生率为33%，高于A组的19%（p=0.292）。A组复发性PRRD的平均发生时间为9.5±5周，B组为2.86±2.41周（p=0.042），B组更多患者最终出现更严重的PVR（p=0.038）。术前所有病例的BCVA均仅为手动（HM），A组术后改善至HM-0.3 Snellen，而B组为光感（PL）-0.1 Snellen（p=0.035）。二次手术在任何方面均无差异，但A组的时间较晚，为9.71±3.73周，B组为4.0±2.83周（p=0.042）。
本研究得出结论，在高危PRRD中使用5-FU和LMWH联合治疗可降低术后PVR的发生率、延迟PRRD的复发并改善最终的BCVA。
注册机构：clinicaltrials.gov，PRS NCT06166914，首次发布日期2023年4月12日。唯一方案识别码：9,163,209，日期2021年10月21日。回顾性注册。
