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A randomized comparison of parecoxib/valdecoxib and placebo for the prevention of cystoid macular edema after scleral buckling surgery . 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 .
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Intervention_Pharmacological
parecoxib/valdecoxib
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Intervention_Control
placebo
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Intervention_Pharmacological
valdecoxib
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Intervention_Control
placebo
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Intervention_Pharmacological
oral valdecoxib
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Intervention_Control
placebo
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Intervention_Pharmacological
parecoxib ( pro-drug of valdecoxib ) intravenously
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Intervention_Control
identical placebo injection
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Intervention_Pharmacological
valdecoxib
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Outcome_Physical
macular edema , retinal thickness , visual acuity , contrast sensitivity and presence of persistent subretinal fluid .
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Outcome_Physical
incidence of macular edema
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Outcome_Other
much lower
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Outcome_Physical
incidence of edema , retinal thickness or visual outcome .
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Outcome_Physical
presence of residual subretinal fluid at the macula
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Participant_Condition
scleral buckling surgery .
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Participant_Condition
scleral buckle surgery
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Participant_Sample-size
116 patients
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Participant_Sample-size
58