Schmoll 2014.
| Methods |
Study design: RCT Study grouping: parallel group, with one eye per participant randomised to one of the interventions Exclusions after randomisation: in all, 108 participants were recruited (including 21 age‐matched "control" participants, who did not receive an IOL and were not included these analyses), of whom 80 completed the study. Of the 28 who did not, 26 voluntarily declined to attend for the second test appointment, one had uncontrolled glaucoma and one required intercurrent hospital admission for an exacerbation of chronic obstructive pulmonary disease. Losses to follow‐up: as described above 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: participants were voluntarily recruited from routine cataract assessment clinics after providing informed consent. Participants were included regardless of whether they were being assessed for first‐ or second‐eye cataract surgery, or as controls. Exclusion criteria: participants unable to read the N48 test display on the reaction time task, those diagnosed with Parkinson’s Disease or dementia, any intercurrent illness requiring hospital admission, any previous ophthalmic history involving retinal damage including proliferative diabetic retinopathy, diabetic macular oedema, exudative AMD, central retinal artery or vein occlusion, and retinal detachment surgery. Comparison of study groups at baseline: not reported |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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| Outcomes | Choice reaction time (CRT) and the Epworth Sleepiness Score (ESS), at three months postoperatively | |
| Identification |
Sponsorship source: Funding sources: not commissioned Declaration of interest: no competing interests Country: Scotland Setting: St Johns Hospital, Livingston, United Kingdom 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: Dr Conrad Schmoll Institution: Princess Alexandra Eye Pavilion Email: conradschmoll@gmail.com Corresponding author's address: Conrad Schmoll Princess Alexandra Eye Pavilion 45 Chalmers Street, Edinburgh EH3 9HA, UK |
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| Notes | None | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "prospective randomised" 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 | Low risk | Quote: "Participants undergoing first‐eye cataract surgery were randomised to receive either a blue‐blocking IOL (Alcon Acrysof SN60WF) or a UV‐blocking IOL (AMO Tecnis ZCB00), and were masked as to which IOL type had been implanted. Study protocol dictated that participants undergoing second‐eye cataract surgery would receive an identical lens to their previous one. These patients had not been issued with information cards after their first‐eye surgery and were therefore unaware of which lens type they received." Judgement comment: participants were reported to be masked; although personnel were reported to be masked, this is not anticipated to significantly affect the study outcomes as most outcome measures were participant‐reported. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: unclear whether outcome assessors were masked |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "108 participants were recruited, of whom 80 completed the study. Of the 28 who did not, 26 voluntarily declined to attend for the second test appointment, one had uncontrolled glaucoma and one required intercurrent hospital admission for an exacerbation of chronic obstructive pulmonary disease." Judgement comment: overall follow‐up < 80%, and follow‐up in each group not reported |
| 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 |