1. Preoperative Bevacizumab for Tractional Retinal Detachment in Proliferative Diabetic Retinopathy: A Prospective Randomized Clinical Trial
- Author
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Arevalo, JF, Lasave, AF, Kozak, I, Al Rashaed, S, Al Kahtani, E, Maia, M, Farah, ME, Cutolo, C, Brito, M, Osorio, C, Navarro, P, Wu, L, Berrocal, MH, Morales-Canton, V, Serrano, MA, Graue-Wiechers, F, Sabrosa, NA, Alezzandrini, AA, Gallego-Pinazo, R, Liu, TYA, Farah, M, Penha, FM, Rodrigues, EB, Fromow-Guerra, J, Naranjo, JLG, Dalma-Weiszhausz, J, Velez-Montoya, R, Quiroz-Mercado, H, Rodriguez, FJ, Gomez, FE, Brieke, AC, Goveto, A, Cruz-Villegas, V, Lozano-Rechy, D, Fulda-Graue, E, Roca, JA, Hernandez, A, Saravia, MJ, Schlaen, A, Rojas, J, Lngolotti, M, Avila, M, Carla, L, Cardillo, J, Jorge, R, Carpentier, C, Verdaguer, J, Verdaguer, JI, Sepulveda, G, Alezzandrini, A, Garcia, B, Zas, M, Diaz-Llopis, M, Dolz-Marco, R, Figueroa, M, Contreras, I, Ruiz-Casas, D, and Pan Amer Collaborative Retina
- Subjects
genetic structures ,sense organs ,eye diseases - Abstract
PURPOSE: To assess the effectiveness and safety of an intravitreal injection of 1.25 mg bevacizumab (IVB) as a preoperative adjunct to small-gauge pars plana vitrectomy (PPV) compared with PPV alone in eyes with tractional retinal detachment secondary to proliferative diabetic retinopathy. METHODS: This prospective, double-masked, randomized, multicenter, active-controlled clinical trial enrolled 224 eyes of 224 patients between November 2013 and July 2015. All eyes underwent a baseline examination including best-corrected visual acuity, color photos, optical coherence tomography, and fluorescein angiography. Data were collected on intraoperative bleeding, total surgical time, early (< 1 month) postoperative vitreous hemorrhage, and mean change in best-corrected visual acuity at 12 months. P < .05 was considered statistically significant. RESULTS: A total of 214 patients (214 eyes) were randomized in a 1:1 ratio to PPV plus IVB ([study group] 102 eyes) or PPV plus sham ([control] 112 eyes). Iatrogenic retinal breaks were noted intraoperatively in 35 eyes (34.3%) in the study group, and 66 eyes (58.9%) in the control group (P = .001). Grade 2 intraoperative bleeding was noted in 32 (31.3%) eyes in the study group and 58 (51.7 %) eyes in the control group (P = .001). Endodiathermy was necessary in 28 (27.4 %) eyes in the study group, compared with 75 (66.9%) eyes in the control group (P = .0001). Mean surgical time was 71.3 +/- 32.1 minutes in the study group and 83.6 +/- 38.7 minutes in the control group (P = .061). CONCLUSION: Preoperative IVB seems to reduce intraoperative bleeding, improving surgical field visualization, and reducing intraoperative and postoperative complications. (C) 2019 Elsevier Inc. All rights reserved.
- Published
- 2019