Leibovitch 2006.
| Methods |
Study design: RCT Study grouping: parallel group, with one eye per participant randomised to one of the interventions Exclusions after randomisation: one of the SN60 (blue‐light filtering) IOL participants was excluded early in the study as he refused to be operated on his other eye. Losses to follow‐up: not reported 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 with age‐related cataracts requiring extraction, but an otherwise normal ocular examination. Exclusion criteria: people with other ocular pathologies, high hyperopia or myopia (6.00 D), or neurological diseases and patients using medications with a possible influence on contrast sensitivity or colour vision. Comparison of study groups at baseline: no significant differences, other than a difference in distribution by sex. A total of 10 participants were randomised to each group but one was dropped from the SN60 group (as they refused to be operated on the other eye). |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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| Outcomes | Distance BCVA (measured using a Snellen chart), contrast sensitivity (Pelli–Robson contrast sensitivity chart) and colour perception (Farnsworth–Munsell D‐15 panel test) at one, three and six months postoperatively The postoperative change in distance BCVA, considered as a dichotomous outcome, was interpreted from the reporting of the study results, "Preoperative BCVA in both groups ranged between 20/30 and 20/200. Postoperative BCVA after six months in the SN60 group was 20/20 or better in all eyes, except 1 (11%), which had a BCVA of 20/30. Postoperative BCVA in the SA60 group was 20/20 or better in all eyes." Intraoperative complications and postoperative complications at six months of follow‐up |
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| Identification |
Sponsorship source: Funding sources: not reported Declaration of interest: not reported Country: Australia 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 First author's name: Igal Leibovitch Institution: Department of Ophthalmology and Visual Sciences, Royal Adelaide Hospital Email: leiboigal5@yahoo.com.au Corresponding author's address: Dr Dinesh Selva Department of Ophthalmology and Visual Sciences Royal Adelaide Hospital North Terrace Adelaide 5000 South Australia, Australia |
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| 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 |
| Allocation concealment (selection bias) | Low risk | Quote: "The patients were randomised to receive one of the two lenses by drawing a blank envelope for each patient out of a box of 20 envelopes. A note in each envelope stated whether an SA60 or SN60 lens would be implanted." Judgement comment: opaque envelopes used for allocation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "All patients were operated by a single surgeon (GP) and were unaware of the type of IOL implanted." Judgement comment: Participants are reported to be masked, but there is no mention of whether personnel were masked. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: no information provided on masking |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: missing data is not explicitly described, but there appears to be 100% participant retention at six months |
| 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 |