AIMS: To assess the impact of valdecoxib on the incidence of macular edema, after scleral buckling surgery. METHODS: Prospective randomized double masked placebo controlled study. Patients undergoing scleral buckle surgery over 18 months were recruited and randomized to receive either oral valdecoxib or placebo. Patients also received two doses of either parecoxib (pro-drug of valdecoxib) intravenously 40 mg 6 hourly day one postoperative or identical placebo injection Patients underwent retinal examination, optical coherence tomography and retinal thickness analyzer scan of the macula preoperatively, and at 2 and 6 weeks postoperatively. Outcome measures were the incidence of macular edema, retinal thickness, visual acuity, contrast sensitivity and presence of persistent subretinal fluid. RESULTS: Interim analysis was performed with 116 patients were recruited, 58 to each treatment arm. The incidence of macular edema in all patients was 5% at visit 1 and 2.2% at visit 2 postoperatively. This incidence was much lower than the expected incidence used in the power calculation to determine study size. It was therefore apparent that a much larger study population would be required to test for an effect and that this was not achievable within the study time period. The study was therefore terminated early. There was no evidence of a difference between COX 2 inhibitor and placebo groups in the incidence of edema, retinal thickness or visual outcome. The presence of residual subretinal fluid at the macula was significantly reduced by COX 2 inhibitor treatment. CONCLUSIONS: The rate of cystoid macular edema after scleral buckling surgery is low and is not influenced by prophylactic use of valdecoxib. The rate of residual subretinal fluid was reduced by COX 2 inhibitor treatment. Enhanced antiinflammatory therapy has the potential to improve outcomes in scleral buckling surgery.
RCT Entities:
AIMS: To assess the impact of valdecoxib on the incidence of macular edema, after scleral buckling surgery. METHODS: Prospective randomized double masked placebo controlled study. Patients undergoing scleral buckle surgery over 18 months were recruited and randomized to receive either oral valdecoxib or placebo. Patients also received two doses of either parecoxib (pro-drug of valdecoxib) intravenously 40 mg 6 hourly day one postoperative or identical placebo injection Patients underwent retinal examination, optical coherence tomography and retinal thickness analyzer scan of the macula preoperatively, and at 2 and 6 weeks postoperatively. Outcome measures were the incidence of macular edema, retinal thickness, visual acuity, contrast sensitivity and presence of persistent subretinal fluid. RESULTS: Interim analysis was performed with 116 patients were recruited, 58 to each treatment arm. The incidence of macular edema in all patients was 5% at visit 1 and 2.2% at visit 2 postoperatively. This incidence was much lower than the expected incidence used in the power calculation to determine study size. It was therefore apparent that a much larger study population would be required to test for an effect and that this was not achievable within the study time period. The study was therefore terminated early. There was no evidence of a difference between COX 2 inhibitor and placebo groups in the incidence of edema, retinal thickness or visual outcome. The presence of residual subretinal fluid at the macula was significantly reduced by COX 2 inhibitor treatment. CONCLUSIONS: The rate of cystoid macular edema after scleral buckling surgery is low and is not influenced by prophylactic use of valdecoxib. The rate of residual subretinal fluid was reduced by COX 2 inhibitor treatment. Enhanced antiinflammatory therapy has the potential to improve outcomes in scleral buckling surgery.
Authors: Vincenza Bonfiglio; Michele Reibaldi; Iacopo Macchi; Matteo Fallico; Corrado Pizzo; Clara Patane; Andrea Russo; Antonio Longo; Alessandra Pizzo; Giovanni Cillino; Salvatore Cillino; Maria Vadalà; Michele Rinaldi; Robert Rejdak; Katarzyna Nowomiejska; Mario Damiano Toro; Teresio Avitabile; Elina Ortisi Journal: J Clin Med Date: 2020-05-21 Impact factor: 4.241
Authors: Cameron Pole; Ismael Chehaibou; Andrea Govetto; Sean Garrity; Steven D Schwartz; Jean-Pierre Hubschman Journal: Int J Retina Vitreous Date: 2021-01-25