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

Kara Junior 2011.

Methods Study design: RCT
Study grouping: parallel group, with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)
Exclusions after randomisation: participants with incomplete follow‐up were not included in the analyses.
Losses to follow‐up: during the five‐year study period, five participants were lost to follow‐up; therefore, 25 participants were considered in the analyses
How missing data were handled: not reported
Reported power size calculation? no
Participants Baseline characteristics
Blue‐light filtering IOL group
  • Number of participants: number of people (number of eyes): 30 (30), with 25 (25) completed

  • Sex (number of women/number of men): 10/15

  • Age (mean ± SD): 59.9 ± 7.0 years


Non‐blue‐light filtering IOL group
  • Number of participants: number of people (number of eyes): 30 (30), with 25 (25) completed

  • Sex (number of women/number of men): 10/15

  • Age (mean ± SD): 59.9 ± 7.0 years


Inclusion criteria: people with visually significant bilateral cataract and no history of colour vision deficiency were eligible for inclusion in the study.
Exclusion criteria: ocular disease such as corneal opacity or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities; surgical complications; IOL tilt; previous or current use of medications known to cause colour‐vision deficiencies; incomplete follow‐up
Comparison of study groups at baseline: paired‐eye trial, however participants who had surgical complications were excluded, and no details were provided about whether there were exclusions due to intraoperative complications.
Interventions Intervention characteristics
Blue‐light filtering IOL
  • Type of IOL: Acrysof Natural SN60AT (Alcon)


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

Outcomes The primary outcome measures were contrast sensitivity, colour vision and macular findings at five years after surgery.
Identification Sponsorship source:
Funding sources: no funding sources listed
Declaration of interest: "No author has a financial or proprietary interest in any material or method mentioned."
Country: Brazil
Setting: Ophthalmology Department, University of Sao Paulo, Sao Paulo, Brazil
Comments:
Date study conducted: not reported
Trial registration number: not reported
Contacting study investigators: study authors contacted not contacted; no additional information used for review
Corresponding author's name: Marcony R. Santhiago, MD
Institution: Cole Eye Institute, Cleveland Clinic
Email: marconysanthiago@hotmail.com
Address: Cole Eye Institute Cleveland Clinic
1700 East 13th Street Apartment 15W, Cleveland, Ohio 44114, USA
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) Unclear risk Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Judgement comment: described as “double‐masked” with no information on who was masked
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Judgement comment: described as “double‐masked” with no information on who was masked
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up), equal follow‐up in both groups (as paired‐eye study) and no obvious reason why loss to follow‐up should be related to outcome
Selective reporting (reporting bias) Unclear risk Judgement comment: no access to protocol or trials registry entry
Other bias Low risk Judgement comment: no other source of bias