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

Vuori 2006.

Methods Study design: RCT
Study grouping: parallel group, involving 37 people (52 eyes)
Exclusions after randomisation: not reported
Losses to follow‐up: not reported
How missing data were handled: in the photographic analysis, two eyes of one participant in the Acrysof Natural IOL group were excluded because of a very lightly pigmented fundus
Reported power size calculation? no
Participants Baseline characteristics
Blue‐light filtering IOL group
  • Number of participants (number of eyes): 19 (25)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 72 ± 8 years


Non‐blue‐light filtering IOL group
  • Number of participants (number of eyes): 18 (27)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 73 ± 7 years


Inclusion criteria: white patients scheduled for phacoemulsification and IOL implantation
Exclusion criteria: hereditary colour vision defects; medications that might affect colour vision, such as ethambutol; any medication for epilepsy; amiodarone; digitalis; anti‐inflammatory drugs; diabetes; any other ocular pathology except cataract
Comparison of study groups at baseline: no apparent group differences, although this was not explicitly stated and sex of participants was not given
Interventions Intervention characteristics
Blue‐light filtering IOL
  • Type of IOL: Acrysof Natural ‐ model SN60AT (Alcon)


Non‐blue‐light filtering IOL
  • Type of IOL: Acrysof ‐ model SA60AT (Alcon)

Outcomes Colour vision (measured using Standard pseudoisochromatic plates, part 2, (SPP2) (Ichikawa et al. 1983) and the FarnsworthMunsell 100‐hue test (FM 100) (Farnsworth 1957)) and visibility of the retinal nerve fibre layer, from retinal fundus photography at one to six months postoperatively
Identification Sponsorship source:
Funding sources: not reported
Declaration of interest: not reported
Country: Finland
Setting: Department of Ophthalmology, Turku University Hopsital, Turku, Finland
Comments:
Date study conducted: not reported
Trial registration number: not reported
Contacting study investigators: study authors not contacted; no additional information used for review
First author's name: Marja‐Liisa Vuori, MD
Institution: Department of Ophthalmology Turku University Hospital, Kiinamyllynkatu 4–8, 20520 Turku, Finland
Email: marja‐liisa.vuori@tyks.fi
Corresponding author's address:
Marja‐Liisa Vuori
Department of Ophthalmology
Turku University Hospital
Kiinamyllynkatu 4–820520 Turku, Finland
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: "Sealed envelopes containing the code for the planned IOL type were used for randomization.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Judgement comment: described as “double blind” with no information on who was masked
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Judgement comment: described as “double blind” with no information on who was masked
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Judgement comment: results suggest no participants were lost to follow‐up; although this is not explicitly stated
Selective reporting (reporting bias) Unclear risk Judgement comment: no access to protocol or trials registry entry
Other bias Unclear risk Judgement comment: sex distribution between study groups at baseline is not reported; the significance of this baseline imbalance is not clear