J Fernando Arevalo1, Andres F Lasave2, Igor Kozak3, Saba Al Rashaed3, Eman Al Kahtani3, Mauricio Maia4, Michel E Farah4, Caroline Cutolo4, Miguel Brito5, Claudia Osorio5, Patricia Navarro5, Lihteh Wu6, María H Berrocal7, Virgilio Morales-Canton8, Martin A Serrano9, Federico Graue-Wiechers10, Nelson Alexandre Sabrosa11, Arturo A Alezzandrini12, Roberto Gallego-Pinazo13. 1. 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. 2. Retina and Vitreous Department, Clínica Privada de Ojos, Mar del Plata, Buenos Aires, Argentina. 3. Vitreoretinal and Uveitis Division, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia. 4. Retina Division, Department of Ophthalmology and Visual Sciences, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil. 5. Instituto Docente de Especialidades Oftalmológicas (IDEO), Maracaibo, Venezuela. 6. Instituto de Cirugia Ocular, San Jose, Costa Rica. 7. Department of Ophthalmology, University of Puerto Rico, San Juan, Puerto Rico. 8. Asociación para Evitar la Ceguera en México, Mexico City, Mexico. 9. Clinica Oftalmologica Centro Caracas and the Arevalo-Coutinho Foundation for Research in Ophthalmology, Caracas, Venezuela. 10. Fundacion Conde Valenciana, Mexico City, Mexico. 11. Clínica de Olhos Gávea, Rio de Janeiro, Brazil. 12. OFTALMOS Universidad de Buenos Aires, Facultad de Medicina, Buenos Aires, Argentina. 13. Consorcio Hospital, General Universitario de Valencia, Valencia, Spain.
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. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.
RCT Entities:
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.
Authors: Albert L Lin; Richard J Roman; Kathleen A Regan; Charlotte A Bolch; Ching-Jygh Chen; Siva S R Iyer Journal: Int J Mol Sci Date: 2020-10-09 Impact factor: 5.923