Monnet 2009.
| Methods |
Study design: RCT Study grouping: parallel group, with one eye per participant randomised to one of the interventions Exclusions after randomisation: Two IOLs in Group 3 (blue‐light filtering IOL group) were placed with one haptic in the capsular bag and one haptic outside the capsular bag; these two participants were also excluded from the final statistical analyses. Losses to follow‐up: one participant in Group 2 (one of the two non‐blue‐light filtering IOL groups) was lost to follow‐up and was not included in the final statistical analyses. How missing data were handled: it appears that missing data were excluded from the analysis. Reported power size calculation? yes |
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| Participants |
Baseline characteristics Blue‐light filtering IOL (Group 3)
Non‐blue‐light filtering IOL1 ‐ MA60AC (Group 1)
Non‐blue‐light filtering IOL2 ‐ SA60AT (Group 2)
Inclusion criteria: people ≥ 60 years, of either sex, of any race, and scheduled for cataract surgery; in good general and ocular health, willing to attend all postoperative visits, and expected to achieve postoperative visual acuities of 20/40 or better Exclusion criteria: people with a history of uveitis, uncontrolled diabetes, diabetic retinopathy, Sjogren syndrome, trauma to the operative eye, use of anti‐inflammatory medications for any reason, use of topical prostaglandin analogues for ocular hypertension or glaucoma, bleeding tendencies, congenital ocular abnormality, or a nonfunctioning fellow eye. people with intraoperative complications including capsule tears, significant anterior chamber hyphema, zonule rupture, or out‐of‐the‐bag IOL implantation. people at risk for intraoperative complications by virtue of pseudoexfoliation syndrome or poor pupil dilation (6.0 mm). people having multiple planned procedures (i.e. cataract and trabeculectomy or corneal transplantation), except those having concurrent relaxing keratotomy for astigmatism correction. Comparison of study groups at baseline: no statistically significant differences between groups in any parameter at baseline, but no data reported for those participants who appear to be excluded from the analyses (n = 1 participant from Group 2, and n = 2 participants from Group 3, but all of Group 2 were included in the demographic data). |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL (Group 3)
Non‐blue‐light filtering IOL1 ‐ MA60AC (Group 1)
Non‐blue‐light filtering IOL2 ‐ SA60AT (Group 2)
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| Outcomes | Postoperative evaluations were performed at one week, one month and three months. All visits included assessment of distance BCVA after manifest refraction, cells, flare, and adverse events. The primary objective of the study was to compare postoperative inflammation (presence of anterior chamber cells and flare) between the three IOL models. Anterior chamber cells were initially graded on a 5‐point scale (0‐4); however, because all eyes were graded 0 or 1, except for 1 eye that was graded 2, values were dichotomised into 2 categories: (1) cell or (2) no cell. |
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| Identification |
Sponsorship source: Funding sources: not reported Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned Country: France Setting: Service d’Ophtalmologie, Universite ´Paris Descartes Hospital Cochin, Paris, France Comments: Date study conducted: not reported Trial registration number: not reported Contacting study investigators: study authors not contacted; no additional information used for review Corresponding author's name: Antoine P. Brezin, MD, PhD Institution: Universite ´ Paris Descartes, Assistance Publique Hopitaux de Paris, Hopital Cochin, Service d’Ophtalmologie Email: antoine.brezin@cch.aphp.fr Corresonding author's address: Antoine P. Brezin Universite ´ Paris Descartes, Assistance Publique Hopitaux de ParisHopital Cochin, Service d’Ophtalmologie 27 rue du Faubourg Saint‐Jacques 75014 Paris, France |
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| Notes | None | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly assigned in a 1:1:1 ratio to receive one of the IOL models according to a randomization list." 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 | High risk | Quote: "single‐center unmasked 3‐month study" Judgement comment: study is described as "unmasked" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "single‐center unmasked 3‐month study" Judgement comment: study is described as "unmasked" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: missing data < 20% (i.e. more than 80% follow‐up) and equal follow‐up in the intervention groups |
| 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 |