Bhattacharjee 2006.
| Methods |
Study design: RCT Study grouping: parallel group, with inter‐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: participants with intraoperative complications were excluded from the analysis; no further details were supplied. 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 ≥ 60 years with good general and ocular health having bilateral age‐related cataracts with a potential visual acuity of 20/40 or better, indicating cataract extraction and IOL implantation (in both eyes), and who agreed to have surgery in both eyes within a maximum interval of 60 days and were willing to complete a schedule of postoperative follow‐ups. Exclusion criteria: people with pre‐existing systemic disease such as diabetes or hypertension, ocular disease, such as uveitis, or who failed the Farnsworth Munsell 100‐Hue test prior to surgery. To avoid the skew deviation of the results, people with an intraoperative complication such as hyphema, zonular rupture, or posterior capsule were also excluded. Comparison of study groups at baseline: no group differences for the 26 eyes (13 participants) that were reported. However, we are unable to judge any potential group difference for participants who were excluded due to intraoperative complications. |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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| Outcomes | Distance BCVA, colour perception and contrast sensitivity at 18 months postoperatively | |
| Identification |
Sponsorship source: Funding sources: Sri Kanchi Sankara Health Educational Foundation, Beltola, Guwahati, Assam, India Declaration of interest: no author had a financial or proprietary interest in any material or method mentioned. Country: India Setting: Sri Sankaradeva Nethralaya Beltola, Assam, India Comments: Date study conducted: June‐August 2003 Trial registration number: not reported Contacting study investigators: we emailed the study authors on 1 September 2017 for the means and standard deviations of the within‐pair differences in distance BCVA at follow‐up; no response was received. As a result, we could not incorporate these data in a meta‐analysis. Corresponding author's name: Harsha Bhattacharjee, MS, Medical Director Institution: Sri Sankaradeva Nethralaya Beltola, Assam, India Email: ssnghy1@sify.com Address: Harsha Bhattacharjee, MS, Medical Director SriSankaradeva Nethralaya Beltola, Guwahati 781028, Assam, India |
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| Notes | None | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "On random selection basis in each patient" 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 | Low risk | Quote: "patient‐masked, examiner‐masked" Judgement comment: clearly states that participants and personnel were not aware of which intervention was received, but surgeon was not masked |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: clearly states that study was "examiner‐masked" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: appears "patients with an intra‐operative complication... were also excluded" so not intention‐to‐treat and no indication of how many participants were excluded on these grounds |
| 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 |