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. 2016 Nov 1;2016(11):CD006683. doi: 10.1002/14651858.CD006683.pub3

Mathys 2010.

Methods Study design: Parallel group RCT
Participants Country: USA
Setting: Eye hospital
Intervention: NSAIDs plus steroids
  • Number of people (eyes) randomised: 42 (42)

  • Number (%) of people followed up: 39 (93%)

  • Average age in years: 74

  • Age range in years: 51‐90

  • Percentage women: 54%

  • Ethnic group: NR

  • Percentage with diabetes: 0 (excluded)

  • Percentage with uveitis: 0 (excluded)


Comparator: Steroids alone
  • Number of people (eyes) randomised: 42 (42)

  • Number (%) of people followed up: 40 (95%)

  • Average age in years: 70

  • Age range in years: 44‐88

  • Percentage women: 53%

  • Ethnic group: NR

  • Percentage with diabetes: 0 (excluded)

  • Percentage with uveitis: 0 (excluded)


Inclusion criteria: Planning to have cataract surgery by KLC at the Ambulatory Care Center, the University of North Carolina Hospitals.
Exclusion criteria: Medically treated diabetes mellitus; history of uveitis;use of topical prostaglandin analogues for glaucoma; history of earlier intraocular surgery in the same eye; retinal vascular disease; macular degeneration;abnormal preoperative OCT measurements.
Pretreatment: Nepafenac group were slightly older, similar gender, preoperative VA, follow‐up time, slightly longer phaco time.
Eyes: One eye, unclear how selected.
Interventions Intervention: NSAIDs plus steroids
  • nepafenac 0.1% (brand name not reported)

    • Times per day: 3 times

    • Duration preoperative: days: 0

    • Duration postoperative: days: 28

  • prednisolone acetate 1% (brand name not reported)

    • Times per day: 4 times

    • Duration preoperative: days: 0

    • Duration postoperative: days: 28


Comparator: Steroids alone
  • prednisolone acetate 1% (brand name not reported)

    • Times per day: 4 times

    • Duration preoperative: days: 0

    • Duration postoperative: days: 28


All participants received nepafenac 0.01% drops in the operated eye thrice, 5 mins apart, immediately before surgery to maintain pupillary dilation and postoperatively, moxifloxacin 0.5% four times a day for 10 days.
Type of surgery: Phacoemulsification
Outcomes Follow‐up: 2 months
  • Change in CRT

  • Adverse effects

  • BCVA logMAR (final value)

Contact details Authors name: KL Cohen
Institution: School of Medicine, University of North Carolina
Email: klc@med.unc.edu
Address: Department of Ophthalmology, School of Medicine, University of North Carolina at Chapel Hill, 5100 Bioinformatics Building, 130 Mason Farm Road, CB no. 7040, Chapel Hill, NC 27599–7040, USA
Notes Funding sources: "This work was supported in part by Research to Prevent Blindness, Inc., New York, NY."
Declaration of interest: "Kenneth C Mathys and Kenneth L Cohen have no financial interest."
Date study conducted: June 2007 to April 2008
Trial registration number: NCT00494494
Contacting study investigators: Trial authors not contacted.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Subjects were randomised according to the even/odd subject identification number, using computer‐generated random numbers, to the control group (standard of care only) or the treatment group (standard of care plus nepafenac)."
Allocation concealment (selection bias) Unclear risk Judgement comment: Not reported how allocation administered.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "were consecutively enrolled in this randomised, non‐masked, parallel‐group clinical trial."
Judgement comment: Participants were not masked.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "At the 2 months visit, technicians, who were masked to treatment, measured ETDRS BCVA, and OCT scans were performed."
Judgement comment: Experienced ophthalmic photographers, who were masked to treatment, obtained Stratus OCT (Carl Zeiss Meditec, Inc., San Francisco, CA, USA) scans using the fast macular thickness protocol.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "The mean time to follow‐up was 73.31 days ( ± 21.58 SD, range 55‐146) in the treatment group and 68.98 days ( ± 13.98, range 50‐120) in the standard‐of‐ care group."
Judgement comment: 39/42 (93%) of intervention group and 40/42 (95%) of comparator group followed‐up. Missing data less than 20% (i.e. more than 80% follow‐up) and equal follow‐up in both groups and no obvious reason why loss to follow‐up should be related to outcome.
Selective reporting (reporting bias) Low risk Judgement comment: Outcomes on trial registry entry were reported.