Marshall 2005.
Methods |
Study design: RCT Study grouping: parallel group, where both eyes were implanted with the same type of IOL and both eyes were used in the analyses (considered as independent samples) Exclusions after randomisation: not reported Losses to follow‐up: not reported How missing data were handled: all eyes that received a test or control IOL and had at least one postoperative examination were included in the postoperative analyses. 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 had to be healthy adults older than 60 years who had bilateral age‐related cataracts. people had to be willing and able to wait at least 30 days (but no more than 60 days) between cataract extraction procedures and had to successfully pass the Ishihara colour test and Farnsworth‐Munsell D‐15 colour perception test preoperatively. Exclusion criteria: people with retinal abnormalities, glaucoma, diabetic retinopathy, and previous or current use of medications known to cause colour‐vision deficiencies. Comparison of study groups at baseline: there were no statistically significant differences between the test and control groups in terms of age, sex, or race (Table 1). |
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Interventions |
Intervention characteristics Blue‐light filtering IOL
Non‐blue‐light filtering IOL
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Outcomes | People were examined 1‐2 days, 7‐14 days, 30‐60 days, 120‐180 days, and 330‐420 days after the first procedure. Screening for IOL implantation in the fellow eye was performed at the 30‐ to 60‐day postoperative examination. Distance BCVA was determined at all postoperative evaluations using the standard Snellen chart. Contrast sensitivity was evaluated at the 30‐ to 60‐day and at the 120‐ to 180‐day postoperative examinations using the CSV‐ 1000E contrast sensitivity unit (Vector Vision) calibrated to assure 85 cd/m2 luminance, under photopic and mesopic conditions. Colour perception was measured at the 30‐ to 60‐day and at the 120‐ to 180‐day postoperative examinations, using the Farnsworth‐Munsell D‐15 colour perception test. Clinical observations of the operative eyes and the IOLs were recorded at each postoperative examination. The occurrence of hyphema, hypopyon, pupillary block, cystoid macular edema, infection or endophthalmitis, retinal detachment, and secondary surgical intervention was noted, as was the presence of IOL tilt, decentration, or dislocation. At all visits through 120 to 180 days, posterior capsule opacification was graded subjectively by slitlamp biomicroscopy as none, clinically nonsignificant, clinically significant, or clinically significant requiring neodymium: YAG (Nd:YAG) laser posterior capsulotomy, using pre‐established criteria. |
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Identification |
Sponsorship source: Funding sources: sponsored by Alcon Laboratories, Inc. Declaration of interest: Drs. Cionni, Lehmann, and Maxwell are consultants to Alcon. No author has a financial or proprietary interest in the materials and methods mentioned Country: USA Setting: multicentre USA clinical trial Comments: Date study conducted: September 2000‐December 2001 Trial registration number: not reported Contacting study investigators: study authors contacted on 1 September 2017 for details relating to the intra‐class correlation for the within‐person clustering, for the outcome measures of: BCVA, proportion of people with cystoid macular oedema at six months, intraoperative complications, and postoperative complications; no response was received after more than one month. First author's name: John Marshall, PhD Institution: Department of Ophthalmology GKT, The Rayne Institute, St. Thomas’ Hospital, London Email: june.spacey@kcl.ac.uk Corresponding author's address: John Marshall Department of Ophthalmology GKT The Rayne Institute, St. Thomas’ Hospital London SE1 7EH, England |
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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) | 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 | High risk | Judgement comment: study described as 'patient‐masked' only, and thus personnel were not masked |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: study described as 'patient‐masked' only |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: although 150 participants implanted with natural IOL and 147 with control (bilateral) only those eyes that had at least 1 postoperative examination were included in the analyses which dropped the numbers to 135 and 127 for BCVA and 109 and 102 for colour. |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no access to protocol or trials registry entry |
Other bias | High risk | Quote: "Philadelphia, Pennsylvania, USA, June 2002. Sponsored by Alcon Laboratories, Inc. Drs. Cionni, Lehmann, and Maxwell are consultants to Alcon. No author has a financial interest." Judgement comment: study was sponsored by Alcon Laboratories, and Drs Cionni, Lehmann and Maxwell were consultants to Alcon |