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 |
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Participants |
Baseline characteristics Blue‐light filtering IOL group
Non‐blue‐light filtering IOL group
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. |
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Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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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 |
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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) | 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 |