Cervantes‐Coste 2009.

Methods	Study design: Parallel group RCT
Participants	Country: Mexico Setting: Eye hospital Intervention: NSAIDs plus steroids Number of people (eyes) randomised: 30 (30) Number (%) of people followed up: 30 (100%) Average age in years: 73 Age range in years: 52 to 88 Percentage women: 67% Ethnic group: NR Percentage with diabetes: 17% Percentage with uveitis: 0 (excluded) Comparator: Steroids alone Number of people (eyes) randomised: 30 (30) Number (%) of people followed up: 30 (100%) Average age in years: 71 Age range in years: 51 to 85 Percentage women: 60% Ethnic group: NR Percentage with diabetes: 23% Percentage with uveitis: 0 (excluded) Inclusion criteria: Adult patients 40 years of age or older; diagnosed with senile and/or metabolic cataract (according to the Lens Opacities Classification System LOCS III, with classification NO and NC 2–3); scheduled for surgery by phacoemulsification and IOL implantation inside the capsular bag; normal fundoscopy exam (if observance was possible). Exclusion criteria: Pregnancy or breastfeeding; history of ocular inflammatory or infectious eye disease; treatment for eye infection within 30 days prior to inclusion in the study;alterations on the eye surface (including dry eye); history of ocular surgery and/or trauma; knowledge or suspicion of allergy or hypersensitivity to the preservatives, steroids, topical NSAIDs, or any other component of the study medication; use of eye medications, including prostaglandin analogues; use of topical or systemic steroids within 30 days prior to inclusion in the study; use of topical or systemic NSAIDs within 14 days prior to inclusion in the study; non‐controlled diabetes mellitus, based on clinical history and blood glucose level (126 mg); proliferative diabetic retinopathy, and/or macular oedema; preoperative mydriasis less than 6 mm prior to the study; synechiae; ocular alteration preventing adequate mydriasis such as iris atrophy; macular alteration documented by OCT, including macular oedema of any etiology, macular holes, epiretinal membrane, macular degeneration related to age, and central serous chorioretinopathy; the use of contact lens in the eye involved during the study. Pretreatment: No differences noted; compared age, gender, operated eye, ocular and systemic pathology. Eyes: One eye, unclear how selected.
Interventions	Intervention: NSAIDs plus steroids nepafenac 0.1% (brand name not reported) Times per day: 1 drop every 15 minutes (4 doses) 1 hour prior to surgery; 3 times a day otherwise Duration preoperative: days: 1 Duration postoperative: days: 42 dexamethasone (combined with tobramycin) (brand name not reported) Times per day: 4 times Duration preoperative: days: 0 Duration postoperative: days: 10 Comparator: Steroids alone dexamethasone (combined with tobramycin) (brand name not reported) Times per day: 4 times Duration preoperative: days: 0 Duration postoperative: days: 10 Type of surgery: Phacoemulsification
Outcomes	Follow‐up: 6 weeks Poor vision outcome due to MO ("None of the patients developed clinically significant macular oedema associated with vision loss") CRT at follow‐up (final value) Adverse effects Inflammation ("inflammatory cells greater than 1+ during first week of postoperative visits") Total macular volume Subgroup analysis by diabetes reported.
Contact details	Authors name: Guadalupe Cervantes‐Coste Institution: Asociación Para Evitar la Ceguera en México I.A.P. Hospital Email: gpecervantes@hotmail.com Address: Av. México 85‐5, México City, 06100 México
Notes	Funding sources: NR Declaration of interest: The authors have no conflicts of interest to disclose. Date study conducted: NR Trial registration number: NR Contacting study investigators: Trial authors not contacted.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "This was a prospective, randomised, single‐masked, single‐center, longitudinal, experimental and comparative study in patients undergoing phacoemulsification cataract surgery." Judgement comment: Not reported how list was generated. Trial described as “randomised” but with no further details.
Allocation concealment (selection bias)	Unclear risk	Judgement comment: Not reported how allocation administered.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The identity of patients receiving preoperative mydriatic or preoperative mydriatic and nepafenac was concealed from the surgeons." Judgement comment: Only the surgeons appeared to be masked.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Judgement Comment: The study compared nepafenac versus no treatment so is essentially open‐label. No information was provided on masking. We assume that in absence of reporting on this outcome, assessors were not masked.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "All patients completed the follow‐up visits over a 6‐week period." Judgement comment: No patients appeared to have been excluded or lost to follow‐up.
Selective reporting (reporting bias)	Unclear risk	Judgement comment: No access to protocol or trial registry entry.