Cristobal 2005.
| Methods |
Study design: RCT Study grouping: parallel group, with inter‐eye comparison (i.e. 1 eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL). Exclusions after randomisation: participants with perioperative or postoperative complications were excluded, but no details were provided about these participants. Losses to follow‐up: people that did not attend follow up or did not use the indicated postoperative medications were excluded, but no details were provided about these participants. 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 requiring bilateral cataract surgery with an IOL implant Exclusion criteria: people who didn't attend follow‐up or didn't use the indicated postoperative medications; with systemic diseases that could influence visual function; with postoperative refractive error > 3.00 D; with perioperative or postoperative complications Comparison of study groups at baseline: no baseline information provided on the included participants |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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| Outcomes | Contrast sensitivity scores with CSV 1000E (®Vistech), for 3, 6, 12 and 18 cycles/degree at 2.6 meters, in scotopic conditions without glare at eight weeks postoperatively Colour vision errors with the Farnsworth test (25 colours) at eight weeks postoperatively participants' subjective measures of self visual function, including colour vision and glare at eight weeks postoperatively BCVA, in decimal scale, at eight weeks postoperatively |
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| Identification |
Sponsorship source: Funding sources: not reported Declaration of interest: not reported Country: not reported Setting: not reported Comments: Date study conducted: not reported Trial registration number: not reported Contacting study investigators: study authors not contacted; no additional information used for review Corresponding author's name: JA Cristobal Institution: Hospital Clínico Universitario Lozano Blesa, Zaragoza, España Email: not reported Address: not reported |
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| Notes | Article in Spanish (translated to English for data extraction) | |
| 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: no information provided on masking. We assume that in absence of reporting on this patients and personnel were not masked. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: no information provided on masking. We assume that in absence of reporting on this outcome assessors were not masked. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: follow‐up not reported, and "patients with perioperative or postoperative complications" were excluded from participation; details of those excluded on these grounds are not provided |
| Selective reporting (reporting bias) | Unclear risk | Judgement comment: no access to protocol or trials registry entry |
| Other bias | Unclear risk | Judgement comment: no baseline information available on the included participants |