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

Autor: Arevalo JF; Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Division of Ophthalmology, Faculty of Health Sciences, University of Stellenbosch, Tygerberg, South Africa. Electronic address: arevalojf@jhmi.edu., Lasave AF; Retina and Vitreous Department, Clínica Privada de Ojos, Mar del Plata, Buenos Aires, Argentina., Kozak I; Vitreoretinal and Uveitis Division, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia., Al Rashaed S; Vitreoretinal and Uveitis Division, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia., Al Kahtani E; Vitreoretinal and Uveitis Division, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia., Maia M; Retina Division, Department of Ophthalmology and Visual Sciences, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil., Farah ME; Retina Division, Department of Ophthalmology and Visual Sciences, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil., Cutolo C; Retina Division, Department of Ophthalmology and Visual Sciences, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil., Brito M; Instituto Docente de Especialidades Oftalmológicas (IDEO), Maracaibo, Venezuela., Osorio C; Instituto Docente de Especialidades Oftalmológicas (IDEO), Maracaibo, Venezuela., Navarro P; Instituto Docente de Especialidades Oftalmológicas (IDEO), Maracaibo, Venezuela., Wu L; Instituto de Cirugia Ocular, San Jose, Costa Rica., Berrocal MH; Department of Ophthalmology, University of Puerto Rico, San Juan, Puerto Rico., Morales-Canton V; Asociación para Evitar la Ceguera en México, Mexico City, Mexico., Serrano MA; Clinica Oftalmologica Centro Caracas and the Arevalo-Coutinho Foundation for Research in Ophthalmology, Caracas, Venezuela., Graue-Wiechers F; Fundacion Conde Valenciana, Mexico City, Mexico., Sabrosa NA; Clínica de Olhos Gávea, Rio de Janeiro, Brazil., Alezzandrini AA; OFTALMOS Universidad de Buenos Aires, Facultad de Medicina, Buenos Aires, Argentina., Gallego-Pinazo R; Consorcio Hospital, General Universitario de Valencia, Valencia, Spain.
Jazyk: angličtina
Zdroj: American journal of ophthalmology [Am J Ophthalmol] 2019 Nov; Vol. 207, pp. 279-287. Date of Electronic Publication: 2019 May 13.
DOI: 10.1016/j.ajo.2019.05.007
Abstrakt: 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. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.
(Copyright © 2019 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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