Brøndsted 2015.
| Methods |
Study design: RCT Study grouping: parallel group, with one eye per participant randomised to one of the interventions Exclusions after randomisation: the publication states that "preoperative and postoperative complications with an impact on visual acuity, including ruptured capsule, nucleus drop, and postoperative corneal oedema, led to exclusion." However, no participants developed postoperative complications leading to exclusion. Losses to follow‐up: a total of 76 participants were enrolled from screening 267 candidates; 73 participants were randomised (n = 35 to a non‐blue‐light filtering IOL and n = 38 to a blue‐light filtering IOL) "because oneparticipant changed her mind regarding the operation and one participant dropped out after the baseline examination and another participant was excluded at the day of the operation because of posterior capsule rupture. Further, one participant found the study procedures too comprehensive and dropped out after the first control visit, producing a final number of 72 participants at the three‐week postoperative visit." How missing data were handled: not reported Reported power size calculation? yes |
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| Participants |
Baseline characteristics Blue‐light filtering IOL group
Non‐blue‐light filtering IOL group
Inclusion criteria: all patients who were referred for bilateral senile cataract surgery to the Department of Ophthalmology, Rigshospitalete Glostrup, Denmark and provided written informed consent Exclusion criteria: ophthalmological disease with an expected effect on the retina, optic disc, or cornea, including advanced AMD, glaucoma, diabetic retinopathy, corneal dystrophy, ocular trauma, and recurrent uveitis; people with severe systemic disease, including diabetes, cancer of any kind, and known sleep disturbances; people with preoperative and postoperative complications with an impact on visual acuity, including ruptured capsule, nucleus drop, and postoperative corneal oedema Comparison of study groups at baseline: there were no significant inter‐group differences at baseline. Participants were similar in terms of age, sex, distance BCVA, cataract severity and circadian type. |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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| Outcomes | Activation of intrinsic photosensitive ganglion cells using post‐illumination pupil response (PIPR) to blue light from 10‐30 s after light exposure as a surrogate measure, before surgery, and at two days and three weeks post‐surgery. Circadian rhythm analysis using actigraphy and 24‐h salivary melatonin measurements before, and at 3 weeks after surgery Objective and subjective sleep quality, as determined by actigraphy and the Pittsburgh Sleep Quality Index before, and at 3 weeks postsurgery |
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| Identification |
Sponsorship source: Funding sources: the study was funded by the Danish Association of the Blind and the Velux Foundation. Declaration of interest: the author(s) have no proprietary or commercial interest in any materials discussed in this article. Country: Denmark Setting: Department of Ophthalmology, Rigshospitalete Glostrup, Denmark Comments: Date study conducted: not reported Trial registration number: clinicaltrials.gov (NCT01686308) Contacting study investigators: study authors not contacted; no additional information used for review Corresponding author's name: Adam Elias Brøndsted, MD Institution: Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark Email: adelbr01@regionh.dk Address: Henrik Ibsens Vej 2, 4.tv, 1813 Frederiksberg C, Denmark |
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| Notes | None | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed on the day of the surgery using automated, computerized block‐randomization lists" |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Because of the different colors of the blue‐blocking and neutral IOLs, it was not possible to keep the investigator masked to IOL type." Judgement comment: Participants were masked but not the "investigator". |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: whether the "same physician (A.E.B)" who examined all particpants was masked or unmasked is not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: 72 of the 76 participants enrolled completed the study |
| Selective reporting (reporting bias) | Low risk | Judgement comment: main outcome measures are as specified in the relevant entry on clinicaltrials.gov |
| Other bias | Low risk | Judgement comment: no other risks of bias identified |