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

Schmidinger 2008.

Methods Study design: RCT
Study grouping: parallel group, with paired‐eye comparison (i.e., one eye received a blue‐light filtering IOL and the fellow eye received a non‐blue‐light filtering IOL)
Exclusions after randomisation: of the 31 participants (enrolled), one was excluded because of subjectively disturbing vitreous floaters and two because of previously undetected macular drusen
Losses to follow‐up: not reported
How missing data were handled: not reported
Reported power size calculation? no
Participants Baseline characteristics
Blue‐light filtering IOL group
  • Number of participants: number of people (number of eyes): 31 (31)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 73.4 ± 7.64 years


Non‐blue‐light filtering IOL group
  • Number of participants: number of people (number of eyes): 31 (31)

  • Sex (number of women/number of men): not reported

  • Age (mean ± SD): 73.4 ± 7.64 years


Inclusion criteria: people with no history of corneal disorders, no abnormal pupil reaction, no sign of inflammation, no opacification of optic media apart from cataract, and no retinal disorders.
Exclusion criteria: people with systemic disease or those having treatment known to affect colour perception. Based on specular microscopy, patients with evident signs of macular alteration or other ocular disease after surgery.
Comparison of study groups at baseline: all participants had a similar cataract grade in both eyes. Baseline age was reported for 28 of the 31 participants. It should be noted that "patients with evident signs of macular alteration or other ocular disease after surgery were not included in the study", however "no intraoperative or postoperative complications or adverse events occurred."
Interventions Intervention characteristics
Blue‐light filtering IOL
  • Type of IOL: AF‐1 (UY) (Hoya)


Non‐blue‐light filtering IOL
  • Type of IOL: AF‐1 (UV) (Hoya)

Outcomes Distance BCVA, colour contrast sensitivity (measured using heterochromic flicker), central and peripheral tritan colour contrast sensitivities (measured using the Moorfields Vision System, CH Electronics) at three months postoperatively.
The primary outcome measure was colour contrast sensitivity for short wavelengths of visible light at three months postoperatively.
Identification Sponsorship source:
Funding sources: not reported
Declaration of interest: no author had a financial or proprietary interest in any material or method mentioned
Country: Austria
Setting: Medical University of Vienna, Department of Ophthalmology, Vienna, Austria
Comments:
Date study conducted: not reported
Trial registration number: not reported
Contacting study investigators: study authors not contacted; no additional information used for review
First author's name: Gerald Schmidinger, MD
Institution: Department of Ophthalmology, Medical University of Vienna
Email: gerald.schmidinger@meduniwien.ac.at
Corresponding author's address:
Gerald Schmidinger
Department of Ophthalmology, Medical University of Vienna Waehringer Guertel 18‐20, A‐1090 Vienna, Austria
Notes None
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 Unclear risk Quote: "double‐blind study"
Judgement comment: study is described as "double‐blind" without specific information on how participants and personnel were masked
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The investigator performing the test was blind to the type of IOL implanted."
Judgement comment: clearly stated that outcome assessors were masked
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up) and no obvious reason why loss to follow‐up should be related to outcome
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