Ticly 2014.
Methods | Study design: Parallel group RCT | |
Participants |
Country: Brazil Setting: Eye hospital Intervention: NSAIDs plus steroids
Comparator: Steroids plus placebo
Included criteria: Nuclear cataract density of 2 and 3 determined by LOCS II; ( > 50 years old); indication for cataract surgery with IOL implantation under local anaesthesia. Excluded criteria: Diabetes; NSAID use; use of topical eye drops (including antiglaucoma drugs); uveitis; macular disease; pseudoexfoliation syndrome; congenital ocular abnormalities; cataract density of 1 and 4 determined by LOCS II; previous intraocular surgery; previous injections; complications during cataract surgery (e.g. posterior capsule rupture, vitreous loss, retained cortical material, or an IOL not placed in the capsular bag); not follow instructions or if they did not show up for appointments. Pretreatment: No major imbalances in age, gender and visual acuity. Eyes: Probably one eye only included in the trial but not clearly reported and unclear how selected. |
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Interventions |
Intervention: NSAIDs plus steroids
Comparator: Steroids plus placebo
Type of surgery: Phacoemulsification |
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Outcomes |
Follow‐up: 5 weeks
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Contact details |
Authors name: Dr. Flavia G. Ticly Institution: Department of Ophthalmology, University of Campinas (UNICAMP), Campinas, Sao Paulo, Brazil Email: flaviaticly@gmail.com Address: Department of OphthalmologyUniversity of Campinas (UNICAMP)P.O. Box 6111Campinas 13083‐970, Sao Paulo, Brazil |
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Notes |
Funding sources: NR Declaration of interest: Reported no competing financial interests exist. Date study conducted: February 2011 to March 2012 Trial registration number: NTC01542190 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) | Unclear risk | Judgement comment: Each of the 2 intervention groups received 50 different numbers from a random number table. These numbers were transferred to small individual envelopes and also affixed to one of the relabeled eye drop bottles. Unclear how this would work. |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: Numbers were transferred to small individual envelopes and also affixed to one of the relabeled eye drop bottles. Unclear how this concealed the allocation. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Judgement comment: Placebo‐controlled study. We assume the masking was effective. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: Placebo‐controlled study. We assume the masking was effective. It was stated that the surgeon and the ophthalmologist who collected the data were not aware of the group assignment of the patients. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: 89% follow‐up. Five patients (10%) did not complete the trial in the placebo group while five patients (11%) did not complete the study in the ketorolac group. |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: No access to protocol or trial registry entry. |