Mathys 2010.
Methods | Study design: Parallel group RCT | |
Participants |
Country: USA Setting: Eye hospital Intervention: NSAIDs plus steroids
Comparator: Steroids alone
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. |
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Interventions |
Intervention: NSAIDs plus steroids
Comparator: Steroids alone
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 |
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Outcomes |
Follow‐up: 2 months
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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 |
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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. |
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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. |