Falkner Radler 2008.
Methods |
Study design: RCT Study grouping: parallel group, with one eye per participant contributing to the analyses Exclusions after randomisation: none apparent Losses to follow‐up: none How missing data were handled: not reported; all participants were reported to complete the final study visit 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: diagnosed vitreoretinal pathologic features, including diabetic vitreous haemorrhage, macular hole, epiretinal membrane, or persisting macula oedema, and coexisting significant cataract; the need for combined surgery, namely pars plana vitrectomy, phaco‐emulsification, and IOL implantation; age > 50 years Exclusion criteria: pseudophakia on the non‐study eye; the need for silicone oil tamponade; optic atrophy Comparison of study groups at baseline: "Patients’ baseline demographic data were comparable between both IOL groups (p>0.05, t test)." |
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Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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Outcomes | Intraoperative conditions for the surgeon, the functional outcome of the surgery (as related to BCVA, contrast sensitivity, colour vision and glare effects), complication rates (intraoperative and postoperative ) and vitreo‐retinal diagnoses, at seven days, one month and three months of follow‐up | |
Identification |
Sponsorship source: Funding sources: none Declaration of interest: none for all authors Country: Austria Setting: the Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery, Department of Ophthalmology, Rudolf Foundation Clinic, Vienna, Austria Comments: Date study conducted: 14 October 2004‐March 2006 Trial registration number: ClinicalTrials.gov NCT00537992 Contacting study investigators: study authors not contacted; no additional information used for review Corresponding author's name: Christiane I. Falkner‐Radler Institution: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Lasersurgery Department of Ophthalmology, Rudolf Foundation Clinic Email: christiane.falkner‐radler@wienkav.at Address: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology Rudolf Foundation Clinic, Juchgasse 25, A‐1030, Vienna, Austria |
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Notes | Interventions In all cases, phacoemulsification (scleral tunnel or clear corneal incision) and IOL implantation were followed by a vitreoretinal procedure. | |
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 | Quote: "The patients included were assigned randomly to receive 30 clear UV‐filter IOLs (clear IOL group) and 30 yellow‐ blue light–filter IOLs (yellow IOL group)." Judgement comment: not reported how allocation was administered. Assignment is described as "random" but without further details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: no information on masking; we assume that in the absence of reporting, patients and personnel were not masked. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "A masked statistical analysis for the questionnaire responses and the other main outcome parameters, namely mean differences between three‐month postoperative and baseline values for distance visual acuity (DVA), near visual acuity (NVA), contrast sensitivity, color vision, and glare effect for each IOL group was performed." Judgement comment: no information was provided in relation to the masking of outcome assessors (only the statistician); we assume that in the absence of reporting, outcome assessors were not masked. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "No patient was lost to follow‐up, and all patients completed the three‐month postoperative follow‐up examination." Judgement comment: no participants were lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no access to a protocol or trials registry entry |
Other bias | Low risk | Judgement comment: no other apparent sources of bias |