Javier Castillo1, Isaac Aleman1, Sloan W Rush2, Ryan B Rush3. 1. Instituto de la Vision - Hospital La Carlota, Nuevo Leon, Mexico. 2. Panhandle Eye Group, Amarillo, Texas; Texas Tech University Health Science Center, Amarillo, Texas. 3. Instituto de la Vision - Hospital La Carlota, Nuevo Leon, Mexico; Panhandle Eye Group, Amarillo, Texas; Texas Tech University Health Science Center, Amarillo, Texas; Southwest Retina Specialists, Amarillo, Texas. Electronic address: Ryanbradfordrush21@hotmail.com.
Abstract
PURPOSE: To assess the optimal interval of preoperative intravitreal bevacizumab (IVB) administration in diabetic subjects undergoing parsplana vitrectomy (PPV) for severe manifestations of active proliferative diabetic retinopathy (PDR). DESIGN: Randomized clinical trial. METHODS:One hundred and fifty-six patients with PDR-related complications requiring PPV were prospectively randomized into 1 of 2 treatment groups: Group A received IVB (2.5 mg/0.1 mL) 1-3 days before PPV, while Group B received IVB (2.5 mg/0.1 mL) 5-10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were intraoperative surgery time, intraoperative complications, postoperative complications, and incidence of unplanned PPV at 6 months follow-up. RESULTS:One hundred and twenty-five subjects underwentPPV and completed the 6-month follow-up interval. Group B patients had better final BCVA (P = .033) and were less likely to have a postoperative complication (P = .018) when compared to Group A patients. The mean difference in final BCVA between groups was 0.22 logMAR (95% confidence interval: 0.02-0.43, P = .017). Group A was 3.90 (95% confidence interval: 1.08-17.31, P = .046) times more likely to have a loss of 1 or more logMAR lines of final BCVA when compared to Group B. There were no significant differences among the treatment groups with regard to baseline features, intraoperative surgery time, intraoperative complications, and incidence of unplanned PPV during the study interval. CONCLUSIONS: This randomized clinical trial demonstrated better postoperative outcomes at 6 months when subjects received preoperative IVB 5-10 days before PPV compared to 1-3 days for the treatment of PDR-related complications.
RCT Entities:
PURPOSE: To assess the optimal interval of preoperative intravitreal bevacizumab (IVB) administration in diabetic subjects undergoing pars plana vitrectomy (PPV) for severe manifestations of active proliferative diabetic retinopathy (PDR). DESIGN: Randomized clinical trial. METHODS: One hundred and fifty-six patients with PDR-related complications requiring PPV were prospectively randomized into 1 of 2 treatment groups: Group A received IVB (2.5 mg/0.1 mL) 1-3 days before PPV, while Group B received IVB (2.5 mg/0.1 mL) 5-10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were intraoperative surgery time, intraoperative complications, postoperative complications, and incidence of unplanned PPV at 6 months follow-up. RESULTS: One hundred and twenty-five subjects underwent PPV and completed the 6-month follow-up interval. Group B patients had better final BCVA (P = .033) and were less likely to have a postoperative complication (P = .018) when compared to Group A patients. The mean difference in final BCVA between groups was 0.22 logMAR (95% confidence interval: 0.02-0.43, P = .017). Group A was 3.90 (95% confidence interval: 1.08-17.31, P = .046) times more likely to have a loss of 1 or more logMAR lines of final BCVA when compared to Group B. There were no significant differences among the treatment groups with regard to baseline features, intraoperative surgery time, intraoperative complications, and incidence of unplanned PPV during the study interval. CONCLUSIONS: This randomized clinical trial demonstrated better postoperative outcomes at 6 months when subjects received preoperative IVB 5-10 days before PPV compared to 1-3 days for the treatment of PDR-related complications.
Authors: Andrea Russo; Antonio Longo; Teresio Avitabile; Vincenza Bonfiglio; Matteo Fallico; Francesco Boscia; Claudio Furino; Salvatore Cillino; Mario Toro; Robert Rejdak; Katarzyna Nowomiejska; Michele Reibaldi Journal: J Clin Med Date: 2019-11-13 Impact factor: 4.241