Wittpenn 2008.

Methods	Study design: Parallel group RCT
Participants	Country: USA Setting: Eye hospital Intervention: NSAIDs plus steroids Number of people (eyes) randomised: 268 (268) Number (%) of people followed up: 227 (85%) given OCT at 4 weeks; 35 (13%) at 6 weeks Average age in years: 70 Age range in years: NR Percentage women: 53% (only reported for whole cohort) Ethnic group: 82% white (only reported for whole cohort) Percentage with diabetes: NR Percentage with uveitis: NR Comparator: Steroids plus placebo Number of people (eyes) randomised: 278 (278) Number (%) of people followed up: 251 (90%) given OCT at 4 weeks; 42 (15%) at 6 weeks Average age in years: 70 Age range in years: NR Percentage women: 53% (only reported for whole cohort) Ethnic group: 82% white (only reported for whole cohort) Percentage with diabetes: NR Percentage with uveitis: NR Inclusion criteria: Scheduled to undergo cataract surgery; 20/20 BCVA potential without any evidence of macular abnormality, including age‐related macular changes, epiretinal membranes, or other retinal‐vascular anomalies. Exclusion criteria: Systemic diseases with ocular manifestations of the disease (e.g. diabetic patients with normal retinal exams were not excluded); vitreous loss or capsular disruption/rupture occurred during surgery; postoperative day 1, the surgeon felt the amount of inflammation was greater than expected and, in his best clinical judgment, more aggressive anti‐inflammatory treatment was indicated. Pretreatment: Quote: "There were no statistically significant between‐group differences in any demographic variable." But no data reported. Eyes: One eye, unclear how selected.
Interventions	Intervention: NSAIDs plus steroids ketorolac 0.4% (Acular LS, Allergan Inc, Irvine, California, USA) Times per day: 4 times a day , 4 doses every 15 minutes one hour preoperative Duration preoperative: days: 3 Duration postoperative: days: 28 to 42 prednisolone acetate 1% (Pred Forte, Allergan Inc) Times per day: 4 times Duration preoperative: days: 0 Duration postoperative: days: "until one 5 ml bottle was empty" Comparator: Steroids plus placebo prednisolone acetate 1% (Pred Forte, Allergan Inc) Times per day: 4 times Duration preoperative: days: 0 Duration postoperative: days: "until they exited the study" placebo (artificial tears) Brand name: NR Times per day: 4 times Duration preoperative: days: 3 Duration postoperative: days: "until one 5 ml bottle was empty" The comparator group: "...also received four drops of ketorolac 0.4% one hour prior to cataract surgery." Type of surgery: Phacoemulsification
Outcomes	Follow‐up: 4 weeks Poor vision outcome due to MO (OCT‐confirmed CMO with visual acuity < 6/9.) Adverse effects CMO (Quote: "Definite CME: Presence of cystoid changes associated with substantial (> 40µm) retinal thickening evident on OCT. 2. Probable CME: Presence of changes in retinal contour and increased macular thickness relative to preoperative baseline, but without definite cystoid changes. 3. Possible CME: Mild to moderate changes in retinal thickness or contour without cystoid changes")
Contact details	Authors name: John R. Wittpenn Institution: State University of New York at Stony Brook Email: jrwittpenn@aol.com Address: State University of New York at Stony Brook, 2500 Route 347, Building 24, Stony Brook, NY 11790
Notes	Funding sources: "This study was supported by an unrestricted education grant from Allergan Inc, Irvine, Calfiornia." Declaration of interest: "The authors indicate no financial conflict of interest." Date study conducted: June 2005 to August 2006 Trial registration number: NCT00348244 Contacting study investigators: Trial authors not contacted.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomised in a 1:1 ratio using a randomly generated list of patient identification numbers."
Allocation concealment (selection bias)	Low risk	Quote: "A central coordination center (IMEDS Inc, Riverside, California, USA; [M.E.]) generated the allocation sequence, enrolled participants, and assigned participants to their treatment groups."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "The patients and technical staff were unmasked because regulations prevented the medications from being repackaged into similar, unmarked bottles. The labels were covered but the technicians were capable of recognizing the bottle color and shape. Patients, however, would only have been unmasked if they researched the type and shape of the different bottles."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "All investigators were masked with regard to treatment group."
Incomplete outcome data (attrition bias) All outcomes	High risk	Judgement comment: Very low follow‐up at 6 weeks. "Of the 546 patients who entered the study, 77 patients also returned for the week‐6 visit, 35 in the ketorolac/steroid group and 42 in the steroid group."
Selective reporting (reporting bias)	Unclear risk	Judgement comment: No access to protocol and trial registry entry did not include outcomes.