Espíndola 2012a.
Methods |
Study design: RCT Study grouping: parallel group, with two study groups (non‐blue‐light filtering IOL vs different non‐blue‐light filtering IOL, n = 25 eyes each per comparison; non‐blue‐light filtering IOL vs blue‐light filtering IOL, n = 27 eyes each per comparison) Exclusions after randomisation: participants with incomplete follow‐up were excluded from the analyses Losses to follow‐up: participants with incomplete follow‐up were excluded from the analyses How missing data were handled: not reported Reported power size calculation? yes |
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Participants |
Baseline characteristics Blue‐light filtering IOLs
Non‐blue‐light filtering IOL
Inclusion criteria: people with visually significant bilateral cataract; people with no history of glaucoma Exclusion criteria: people with any ocular disease, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, retinal abnormalities, surgical complications, IOL tilt, previous or current use of medications known to cause colour‐vision deficiencies, or incomplete follow‐up Comparison of study groups at baseline: paired eye study; no group differences reported and "no eye had intraoperative complications" |
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Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOLs
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Outcomes | The primary outcome measures were contrast sensitivity (photopic and mesopic) and blue‐on‐yellow perimetry values (mean deviation and pattern standard deviation), at two years postoperatively Safety outcomes were the rate of intraoperative complications and the proportion of participants requiring capsulotomy at two years postoperatively |
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Identification |
Sponsorship source: Funding sources: no specific financial support Declaration of interest: no potential conflicts of interest for any authors Country: Brazil Setting: Study conducted in Ophthalmology Department of the University of São Paulo, São Paulo, Brazil Comments: Date study conducted: not reported Trial registration number: not reported Contacting study investigators: study authors not contacted; no additional information used for review Corresponding author's name: Rodrigo F. Espíndola Institution: Ophthalmology Department of the University of São Paulo, São Paulo, Brazil Email: rodrigo166@uol.com.br Address: Rodrigo F. EspíndolaPraça das Hortências, 70 ‐ Itu (SP) ‐ 13301‐689 ‐ Brazil |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: not reported how list was generated. Study is described as “randomised” but with no further details |
Allocation concealment (selection bias) | Low risk | Quote: "Sequenced and sealed envelopes containing the first type of IOL (Akreos AO or Akreos Fit; SN60AT or MA60AC) were prepared before surgery. An unscrubbed observer in the operating room opened the envelopes and assigned each patient." Judgement comment: clearly states how the intervention allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All patients and observers were masked about the IOL type implanted." Judgement comment: clearly states that all participants and observers were masked to the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The observers who conducted the postoperative visual evaluations did not have access to the randomization code or information about the surgical procedures." Judgement comment: clearly states that outcome assessors were masked |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "All patients completed 24 months of follow‐up." Judgement comment: although the paper states "All patients completed 24 months of follow‐up", an exclusion criterion was that "Patients with surgical complications or incomplete follow‐up were excluded". Although "there were no eyes with intraoperative complications," it is unclear whether follow‐up was 100‐percent for all participants as this was an exclusion criterion. |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no access to protocol or trials registry entry |
Other bias | Low risk | Judgement comment: no other apparent sources of bias |