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. 2018 May 22;2018(5):CD011977. doi: 10.1002/14651858.CD011977.pub2

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
Participants Baseline characteristics
Blue‐light filtering IOLs
  • Number of participants: number of people (number of eyes): 27 (27)

  • Sex (number of women/number of men): 7/20

  • Age (mean ± unit of error): 68.5 ± 3.84 years (unit of error not specified)


Non‐blue‐light filtering IOL
  • Number of participants: number of people (number of eyes): 52 (77)

  • Sex (number of women/number of men): 20/32

  • Age (mean ± unit of error): not reported


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"
Interventions Intervention characteristics
Blue‐light filtering IOL
  • Type of IOL: AcrySof Natural SN60AT (Alcon)


Non‐blue‐light filtering IOLs
  • Type of IOL: Akreos Fit (Bausch & Lomb) or Akreos AO (Bausch & Lomb) or AcrySof SA60AT (Alcon ‐ but also described as MA60AC in the paper)

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
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
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