Caporossi 2007.
| Methods |
Study design: RCT Study grouping: parallel group, where both eyes of each participant were randomised to the same type of intervention Exclusions after randomisation: participants with intraoperative complications, IOL tilt or decentration were excluded from the analyses; however, no participant had these complications Losses to follow‐up: none How missing data were handled: not reported Reported power size calculation? no |
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| Participants |
Baseline characteristics Blue‐light filtering IOL group 1 ‐ SN60AT (Alcon)
Non‐blue‐light filtering IOL group 1 ‐ Tecnis Z9000 (AMO)
Blue‐light filtering IOL group 2 ‐ SN60WF (Alcon)
Non‐blue‐light filtering IOL 2 ‐ Sensar AR40e (AMO)
Non‐blue‐light filtering IOL 3 ‐ Sofport L161AO (Bausch & Lomb)
Inclusion criteria: people aged between 50 and 80 years, bilateral cataracts, potential acuity better than 0.2 logMAR units, preoperative corneal spherical aberration (Z04) values between 0.1 and 0.25μm at 5‐mm pupil diameter, and IOL power between +18.00 and +24.00 diopters (D) Exclusion criteria: people were excluded if any of the following conditions were present: corneal astigmatism ≥ 1.00 D, surgical complications, IOL tilt and decentration estimated by retroillumination, glaucoma, amblyopia, corneal pathology, history of uveitis, diabetic retinopathy, pseudoexfoliation syndrome, macular pathology, and previous intraocular surgery. People using topical medications (apart from lubricants) and taking systemic steroids also were excluded. Comparison of study groups at baseline: there were no statistically significant differences among the groups in terms of participant age (P > 0.05). |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL 1
Non‐blue‐light filtering IOL 1
Blue‐light filtering IOL 2
Non‐blue‐light filtering IOL 2
Non‐blue‐light filtering IOL 3
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| Outcomes | BCVA, contrast sensitivity (mesopic and photopic), corneal abberations and wavefront spherical aberration of the whole eye, at two months postoperatively intraoperative complications and postoperative complications at two months postoperatively |
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| Identification |
Sponsorship source: Funding sources: not reported Declaration of interest: "the authors have no proprietary interest in the materials presented herein" Country: Italy Setting: Department of Ophthalmology and Neurosurgery at the University of Siena, Italy Comments: Date study conducted: not reported Trial registration number: not reported Contacting study investigators: authors contacted on 14th August 2017, Re: Table 2 – whether units of error show SD or another unit (as not specified in the paper); no response was received Corresponding author's name: Gianluca Martone, MD Institution: Department of Ophthalmology and Neurosurgery at the University of Siena, Italy Email: gianlucamartone@unisi.it Address: Gianluca Martone, MD Dipartimento di Scienze Oftalmologiche e NeurochirurgicheUniversità degli Studi di Siena, Viale Bracci 1, 53100 Siena, Italy |
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| Notes | Data reported in this study for the SN60AT, SN60WF, Sensar AR40e, Tecnis Z900 participants (n = 100 people, n = 200 eyes) is the same as for the Caporossi 2009 paper (which reports later follow‐up time points for these participants). | |
| 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 | High risk | Judgement comment: participants were masked to which IOL they received; however, there is no comment regarding other personnel, so we assume that in the absence of this information, the study personnel were not masked. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: we assume that in absence of reporting, the outcome assessors were not masked. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: participants with “surgical complications, IOL tilt and decentration estimated by retroillumination” were excluded, but the paper also states that “no intraoperative or postoperative complications were recorded in the study. In particular no cases of significant IOL decentration and tilt developed during the follow‐up. Further, for the 125 participants enrolled in the study, none of the 125 patients dropped out of the study.” |
| 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 |