Preoperative Bevacizumab for Tractional Retinal Detachment in Proliferative Diabetic Retinopathy: A Prospective Randomized Clinical Trial

被引:30
作者
Arevalo, J. Fernando [1 ,2 ,16 ]
Lasave, Andres F. [3 ,10 ,11 ]
Kozak, Igor [4 ]
Al Rashaed, Saba [4 ]
Al Kahtani, Eman [4 ]
Maia, Mauricio [5 ,18 ]
Farah, Michel E. [5 ]
Cutolo, Caroline [5 ]
Brito, Miguel [6 ]
Osorio, Claudia [6 ]
Navarro, Patricia [6 ]
Wu, Lihteh [7 ,17 ]
Berrocal, Maria H. [8 ]
Morales-Canton, Virgilio [9 ]
Serrano, Martin A. [10 ,11 ]
Graue-Wiechers, Federico [12 ]
Sabrosa, Nelson Alexandre [13 ]
Alezzandrini, Arturo A. [14 ]
Gallego-Pinazo, Roberto [15 ]
Liu, T. Y. A. [16 ]
Farah, M. [18 ]
Penha, F. M. [18 ]
Rodrigues, E. B. [18 ]
Fromow-Guerra, J. [9 ]
-Naranjo, J. L. Guerrero [9 ]
Dalma-Weiszhausz, J. [9 ]
Velez-Montoya, R. [9 ]
Quiroz-Mercado, H. [9 ]
Rodriguez, F. J. [19 ]
Gomez, F. E. [19 ]
Brieke, A. C. [19 ]
Goveto, A. [19 ]
Berrocal, M. H. [20 ]
Cruz-Villegas, V. [20 ]
Lozano-Rechy, D. [12 ]
Fulda-Graue, E. [12 ]
Roca, J. A. [21 ]
Hernandez, A. [21 ]
Saravia, M. J. [22 ]
Schlaen, A. [22 ]
Rojas, J. [22 ]
Lngolotti, M. [22 ]
Avila, M. [23 ]
Carla, L. [23 ]
Cardillo, J. [24 ,25 ]
Jorge, R. [24 ,25 ]
Carpentier, C. [26 ]
Verdaguer T, J. [26 ]
Verdaguer D, J. I. [26 ]
Sepulveda, G. [26 ]
机构
[1] Johns Hopkins Univ, Sch Med, Wilmer Eye Inst, Retina Div, Baltimore, MD 21205 USA
[2] Univ Stellenbosch, Fac Hlth Sci, Div Ophthalmol, Tygerberg, South Africa
[3] Clin Privada Ojos, Retina & Vitreous Dept, Buenos Aires, DF, Argentina
[4] King Khalid Eye Specialist Hosp, Vitreoretinal & Uveitis Div, Riyadh, Saudi Arabia
[5] Fed Univ Sao Paulo UNIFESP, Dept Ophthalmol & Visual Sci, Retina Div, Sao Paulo, SP, Brazil
[6] IDEO, Maracaibo, Venezuela
[7] Inst Cirugia Ocular, San Jose, Costa Rica
[8] Univ Puerto Rico, Dept Ophthalmol, San Juan, PR 00936 USA
[9] Asociac Evitar Ceguera Mexico, Mexico City, DF, Mexico
[10] Clin Oftalmol Ctr Caracas, Caracas, Venezuela
[11] Arevalo Coutinho Fdn Res Ophthalmol, Caracas, Venezuela
[12] Fdn Conde Valenciana, Mexico City, DF, Mexico
[13] Clin Olhos Gavea, Rio De Janeiro, Brazil
[14] OFTALMOS Univ Buenos Aires, Fac Med, Buenos Aires, DF, Argentina
[15] Gen Univ Valencia, Consorcio Hosp, Valencia, Spain
[16] Johns Hopkins Univ, Wilmer Eye Inst, Baltimore, MD 21218 USA
[17] Asociados Macula Vitreo & Retina Costa Rica, San Jose, Costa Rica
[18] Univ Fed Sao Paulo, Dept Oftalmol, Inst Visao, Sao Paulo, SP, Brazil
[19] Univ Rosario, Fdn Oftalmol Nacl, Bogota, Colombia
[20] Univ Puerto Rico, San Juan, PR 00936 USA
[21] Clin Ricardo Palma, Lima, Peru
[22] Hosp Univ Austral, Buenos Aires, DF, Argentina
[23] Univ Fed Goias, Dept Oftalmol, Goiania, Go, Brazil
[24] Hosp Olhos Araraquara, Sao Paulo, SP, Brazil
[25] Univ Sao Paulo, Sao Paulo, SP, Brazil
[26] Fdn Oftalmol Los Andes, Santiago, Chile
[27] Univ Buenos Aires, Catedra Oftalmol, OFTALMOS, Buenos Aires, DF, Argentina
[28] Univ Valencia, Hosp La Fe, Valencia, Spain
[29] Hosp Univ Ramon y Cajal, Dept Retina, Madrid, Spain
[30] VISSUM Madrid, Madrid, Spain
关键词
INTRAVITREAL BEVACIZUMAB; IRIS NEOVASCULARIZATION; VISUAL-LOSS; VITRECTOMY; INJECTION; AVASTIN; ADJUNCT; MANAGEMENT; REGRESSION; SURGERY;
D O I
10.1016/j.ajo.2019.05.007
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
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.
引用
收藏
页码:279 / 287
页数:9
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