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. 2018 May 22;2018(5):CD011977. doi: 10.1002/14651858.CD011977.pub2

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
Participants Baseline characteristics
Blue‐light filtering IOL group
  • Number of participants: number of people (number of eyes): 30 (30)

  • Sex (number of women/number of men): 24/6

  • Age (mean): 68 years (unit of error not specified)


Non‐blue‐light filtering IOL group
  • Number of participants: number of people (number of eyes): 30 (30)

  • Sex (number of women/number of men): 19/11

  • Age (mean): 66 years (unit of error not specified)


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)."
Interventions Intervention characteristics
Blue‐light filtering IOL
  • Type of IOL: AcrySof natural single‐piece (Alcon) or Hoya AF‐1 UY single‐/three‐piece (Polytech Ophthalmologie)


Non‐blue‐light filtering IOL
  • Type of IOL: AcrySof single‐piece (Alcon) or Hoya AF‐1 UV single‐/three‐piece (Polytech Ophthalmologie)

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
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