Caporossi 2009.
| Methods |
Study design: RCT Study grouping: parallel group, where both eyes of each participant were randomised to the same type of intervention (as per the Caporossi 2007 study) Exclusions after randomisation: 2‐year follow‐up data from participants in the Caporossi 2007 study Losses to follow‐up: none at 2 months postoperatively, 6 participants (12 eyes) at 1 year postoperatively and 11 participants (22 eyes) at 2 years postoperatively 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)
Inclusion criteria: people aged between 50 and 80 years, bilateral cataracts, potential acuity > 0.2 logMAR units, preoperative corneal spherical aberration (Z04) values between 0.1 and 0.25 pm at 5 mm pupil diameter, and IOL power between + 18.00 and + 24.00 diopters (D) Exclusion criteria: people with any of the following present: corneal astigmatism of 1.00 D or more, surgical complications, IOL tilt and decent ration estimated by retroillumination, glaucoma, amblyopia, corneal pathology, history of uveitis, diabetic retinopathy, pseudoexfoliation syndrome, macular pathology, or previous intraocular surgery. People using topical medications (apart from lubricants) or systemic steroids Comparison of study groups at baseline: no statistically significant differences among groups in terms of age (P > 0.05) were noted. |
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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
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| Outcomes | BCVA, contrast sensitivity (mesopic and photopic), pupil size, corneal abberations and wavefront spherical aberration of the whole eye, at two months, one year and two years postoperatively Postoperative complications (Nd:YAG capsulotomies) at two years 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, University of Siena, Italy Comments: Date study conducted: surgeries performed between March 2004‐July 2005 Trial registration number: not reported Contacting study investigators: authors contacted on 14 August 2017 regarding distance BCVA and contrast sensitivity units of error (specifically, whether it is the SD or a different unit or error). We also asked for clarification with regard to why the longer‐term follow‐up data for individuals fitted with the Sofport L161AO lens (described in the earlier paper by Caporossi 2007, are not reported here). No response was received to the email, and as a consequence we could not incorporate these data in the meta‐analyses. Corresponding author's name: Gianluca Martone, MD Institution: Department of Ophthalmology, University of Siena, Italy Email: gianlucamartone@unisi.it Address: Gianluca Martone, MDVia Fontenuovu n.2O, 53100, Siena, Italy |
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| Notes | Outcomes:We had already considered the rate of intraoperative complications in this group of participants in Caporossi 2007, so we did not extract the data again from this paper. | |
| 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 was administered. Study is described as “randomised” but with no further details |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: we assume that in the absence of reporting, neither participants nor study personnel were masked. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: we assume that in the absence of reporting, the outcome assessors were not masked. |
| Incomplete outcome data (attrition bias) All outcomes | Low 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. At two years postoperatively, 89 participants (178 eyes) out of 200 participants remained in the study; reasons for incomplete follow‐up are included (Table 2), and this is relatively equal across the four intervention groups. Although, note that the Caporossi 2007 paper, which reported baseline and two‐month follow‐up data for the same participants, included five lens types rather than four lens types (data relating to the Sofport L161AO lens are not included in this paper, without explanation). |
| 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 |