Carlos A Moreira-Neto, Jose S Pulido, Luca Bongiovanni de Miranda Gonçalves, Gabriel Nunes Cavalcanti, Acacio Souza Lima, José de Paula Barbosa Neto, Daniel Lavinsky, Talita Virginia Fernandes de Oliveira, Fernando Ejii Ogata, Lucas Zago Ribeiro, Luiz Fernando Teixeira, Flavia Borelli Gomes do Nascimento, Luiz H Lima, Octaviano Jr Magalhães, Michel Eid Farah, Maurício Maia
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We evaluated the safety and efficacy of 5 µg/0.1 ml intravitreal melphalan at the end of pars plana vitrectomy (PPV) before silicone oil (SO) injection in eyes with primary PVR related to rhegmatogenous retinal detachments (RRDs) with a minimal 90-day follow-up period.</p><p><strong>Methods: </strong>This prospective, cross-sectional, interventional pilot study was conducted at the Department of Ophthalmology of the Federal University of São Paulo in patients with primary RRD and PVR. Patients were included who were aged 18 to 85 years with PVR grade CP2 or worse secondary to RRDs in eyes without having undergone a previous RRD surgery. They underwent PPV + scleral buckle + fluid air exchange followed by intravitreal injection of 5 µg/0.1 ml melphalan (270 mOsm) and SO injection.</p><p><strong>Results: </strong>Six eyes of six patients were enrolled. Ocular examination and imaging showed no retinal toxicity. The logarithm of the minimum angle of resolution best-corrected visual acuity improved from the mean ± standard deviation preoperatively of 2.11 ± 0.22 to 0.89 ± 0.37 at 30 and to 0.84 ± 0.42 at 90 days postoperative (P < 0.001). Optical coherence tomography identified intraretinal cysts in five of six eyes and outer retinal layer loss in all study eyes. Only one of six eyes developed a recurrent localized RD on day 90 unrelated to recurrent PVR. PVR recurrence was not observed during the study follow-up.</p><p><strong>Conclusions: </strong>In this pilot study, the preliminary data showed that PPV followed by intravitreal injection of 5 µg/0.1 ml melphalan was not related to ocular toxicity. 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They underwent PPV + scleral buckle + fluid air exchange followed by intravitreal injection of 5 µg/0.1 ml melphalan (270 mOsm) and SO injection.</p><p><strong>Results: </strong>Six eyes of six patients were enrolled. Ocular examination and imaging showed no retinal toxicity. The logarithm of the minimum angle of resolution best-corrected visual acuity improved from the mean ± standard deviation preoperatively of 2.11 ± 0.22 to 0.89 ± 0.37 at 30 and to 0.84 ± 0.42 at 90 days postoperative (P < 0.001). Optical coherence tomography identified intraretinal cysts in five of six eyes and outer retinal layer loss in all study eyes. Only one of six eyes developed a recurrent localized RD on day 90 unrelated to recurrent PVR. PVR recurrence was not observed during the study follow-up.</p><p><strong>Conclusions: </strong>In this pilot study, the preliminary data showed that PPV followed by intravitreal injection of 5 µg/0.1 ml melphalan was not related to ocular toxicity. 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引用次数: 0
摘要
背景：增殖性玻璃体视网膜病变（PVR）是视网膜脱离（RD）修复失败的主要原因。玻璃体内美法兰是一种已知的细胞增殖抑制剂，为减少PVR复发和改善预后提供了一种新的治疗方法。我们通过至少90天的随访，评估了玻璃体切割（PPV）结束时玻璃体内注射5µg/0.1 ml melphalan，然后再注射硅油（SO）治疗与孔源性视网膜脱离（rrd）相关的原发性PVR的安全性和有效性。方法：这项前瞻性、横断面、介入性的初步研究是在圣保罗联邦大学眼科对原发性RRD和PVR患者进行的。纳入的患者年龄在18至85岁之间，患有PVR级CP2或更糟的眼部继发RRD，此前未接受过RRD手术。患者行PPV +巩膜扣带+液体空气交换，玻璃体内注射5µg/0.1 ml美法兰（270 mOsm）和注射SO。结果：6例患者6只眼入组。眼部检查及影像学未见视网膜毒性。最佳矫正视力最小分辨角的对数由术前平均±标准差2.11±0.22提高到术后30天的0.89±0.37和术后90天的0.84±0.42 (P)。结论：在本初步研究中，初步数据显示PPV术后玻璃体内注射5µg/0.1 ml melphalan与眼毒性无关。在这些复杂的PVR眼中，随访3个月无PVR复发是一个有趣的发现，值得进一步研究。
A pilot study of intraoperative melphalan to prevent recurrent PVR: the IOMPVR study.
Background: Proliferative vitreoretinopathy (PVR) is a major cause of failure in cases of retinal detachment (RD) repair. Intravitreal melphalan, a known inhibitor of cellular proliferation, offers a novel therapeutic approach to reduce PVR recurrence and improve outcomes. We evaluated the safety and efficacy of 5 µg/0.1 ml intravitreal melphalan at the end of pars plana vitrectomy (PPV) before silicone oil (SO) injection in eyes with primary PVR related to rhegmatogenous retinal detachments (RRDs) with a minimal 90-day follow-up period.
Methods: This prospective, cross-sectional, interventional pilot study was conducted at the Department of Ophthalmology of the Federal University of São Paulo in patients with primary RRD and PVR. Patients were included who were aged 18 to 85 years with PVR grade CP2 or worse secondary to RRDs in eyes without having undergone a previous RRD surgery. They underwent PPV + scleral buckle + fluid air exchange followed by intravitreal injection of 5 µg/0.1 ml melphalan (270 mOsm) and SO injection.
Results: Six eyes of six patients were enrolled. Ocular examination and imaging showed no retinal toxicity. The logarithm of the minimum angle of resolution best-corrected visual acuity improved from the mean ± standard deviation preoperatively of 2.11 ± 0.22 to 0.89 ± 0.37 at 30 and to 0.84 ± 0.42 at 90 days postoperative (P < 0.001). Optical coherence tomography identified intraretinal cysts in five of six eyes and outer retinal layer loss in all study eyes. Only one of six eyes developed a recurrent localized RD on day 90 unrelated to recurrent PVR. PVR recurrence was not observed during the study follow-up.
Conclusions: In this pilot study, the preliminary data showed that PPV followed by intravitreal injection of 5 µg/0.1 ml melphalan was not related to ocular toxicity. The absence of PVR recurrence at 3 months follow-up in these complex PVR eyes is an interesting finding that justifies further investigation.
期刊介绍：
International Journal of Retina and Vitreous focuses on the ophthalmic subspecialty of vitreoretinal disorders. The journal presents original articles on new approaches to diagnosis, outcomes of clinical trials, innovations in pharmacological therapy and surgical techniques, as well as basic science advances that impact clinical practice. Topical areas include, but are not limited to: -Imaging of the retina, choroid and vitreous -Innovations in optical coherence tomography (OCT) -Small-gauge vitrectomy, retinal detachment, chromovitrectomy -Electroretinography (ERG), microperimetry, other functional tests -Intraocular tumors -Retinal pharmacotherapy & drug delivery -Diabetic retinopathy & other vascular diseases -Age-related macular degeneration (AMD) & other macular entities
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