Nolan 2009.
| Methods |
Study design: RCT Study grouping: parallel group, involving 42 participants; it does not state whether the IOLs were unilaterally or bilaterally implanted Exclusions after randomisation: one participant from the AIOL group withdrew after Visit 1 (V1), two after Visit 2 (V2), and two after Visit 4 (V4) (n = 5 withdrawals in total). Three participants from the ANIOL group withdrew after V1, two after V2, and two after V4 (n = 7 withdrawals in total). The reasons for withdrawal were as follows: illness (non‐ocular); participant deceased; logistics of transport; and not interested in participating further Losses to follow‐up: Of the 42 participants recruited, 30 attended all study visits (one week before surgery, one week after surgery, and three, six, and 12 months after surgery: V1, V2, V3, V4, and V5, respectively) How missing data were handled: not reported Reported power size calculation? no |
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| Participants |
Baseline characteristics Blue‐light filtering IOL group (ANIOL group)
Non‐blue‐light filtering IOL group (AIOL group)
Inclusion criteria: people scheduled for cataract surgery at Waterford Regional Hospital Exclusion criteria: pre‐operative logMAR visual acuity of less than 0.5 (the minimum required for reliable measurement of MPOD) and those with any evidence of macular disease Comparison of study groups at baseline: groups were similar in age (P = 0.370) and sex distribution. The mean BMI was higher in the AIOL group compared with the ANIOL group (P = 0.017) |
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| Interventions |
Intervention characteristics Blue‐light filtering IOL (ANIOL)
Non‐blue‐light filtering IOL (AIOL)
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| Outcomes | The spatial profile of MPOD (i.e. at 0.25°, 0.5°, 1.0°, and 1.75° eccentricity) was measured with customised heterochromatic flicker photometry (cHFP) one week before and one week after surgery, and at three, six, and 12 months after surgery. Serum concentrations of lutein and zeaxanthin were measured at each study visit. BCVA, reported as a "Visual Acuity Rating" at 12 months postoperatively. |
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| Identification |
Sponsorship source: Supported in full by Alcon Laboratories Inc., Fort Worth, Texas. Disclosure: "J.M. Nolan, Alcon Laboratories Inc. (F); P. O’Reilly, Alcon Laboratories Inc. (F); J. Loughman, Alcon Laboratories Inc. (F); J. Stack, Alcon Laboratories Inc. (F); E. Loane, Alcon Laboratories Inc. (F); E. Connolly, Alcon Laboratories Inc. (F); S. Beatty, Alcon Laboratories Inc. (F) The publication costs of this article were defrayed in part by page charge payment. This article must therefore be marked “advertisement” in accordance with 18 U.S.C. §1734 solely to indicate this fact." Country: Ireland Setting: Waterford Regional Hospital, Ireland Comments: Date study conducted: not reported Trial registration number: not reported Contacting study investigators: study authors not contacted; no additional information provided for review Authors name: John M. Nolan Institution: Macula Pigment Research Group, Waterford Institute of Technology, Cork Road, Waterford, Ireland Email: jnolan@wit.ie Address: Macula Pigment Research Group, Waterford Institute of Technology, Cork Road, Waterford, Ireland |
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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. 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: "The trial was conducted in a double‐blind, randomised, controlled fashion." Judgement comment: described as “double blind” with no information on who was masked |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: described as “double blind” with no information on who was masked |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Forty‐two patients were recruited. The patients were randomised to receive either the AIOL (n = 21) or the ANIOL (n = 21) implant as a lens replacement in their cataract surgery. Of the 42 patients recruited, 30 attended all study visits (one week before surgery, one week after surgery, and three, six, and 12 months after surgery: V1, V2, V3, V4, and V5, respectively). One patient from the AIOL group withdrew after V1, two after V2, and two after V4 (n = 5 withdrawals in total). Three patients from the ANIOL group withdrew after V1, two after V2, and two after V4 (n = 7 withdrawals in total). The reasons for withdrawal were as follows: patient illness (non‐ocular); patient deceased; logistics of transport; and not interested in participating further." |
| Selective reporting (reporting bias) | Unclear risk | Judgement comment: no access to protocol or trials registry entry |
| Other bias | High risk | Quote: "Supported in full by Alcon Laboratories Inc., Fort Worth, Texas... The publication costs of this article were defrayed in part by page charge payment. This article must therefore be marked “advertisement” in accordance with 18 U.S.C. §1734 solely to indicate this fact." Judgement comment: industry funding (Alcon Laboratories), who manufactured the interventions |