Ma 2012.
Methods | Parallel group RCT Method of allocation: not described Masking: participant ‐ yes; provider ‐ yes; outcome ‐ yes Loss to follow‐up: unclearly reported but could be 1/108 |
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Participants | Country: China Number of people randomised: 108 (eyes unknown) Number (%) of people followed up: 107 (99%) (eyes unknown) Average age (range): 69 (unknown) Percentage women: 58% Ethnic group: unknown Baseline visual acuity: 0.30 logMAR Comorbidities affecting the eye: 23% early cataracts Percentage current smokers: 6% Inclusion criteria:
Exclusion criteria
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Interventions | Intervention:
Comparator:
Duration: 12 months Similarity between intervention and comparator: unclear, placebo was not described |
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Outcomes | From the published paper: Primary:
Secondary:
From clinical trials.gov (registered retrospectively): Primary Outcome Measures: MPOD and multifocal electroretinograms (time frame: 1 year) Secondary Outcome Measures: risk of advanced AMD. (time frame: 1 year) Follow‐up: 24 weeks and 48 weeks Eyes: unclear how many eyes included in study |
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Notes | Source of funding: Quote: "Supported by the National Natural Science Foundation of China (grant no.: NSFC‐30872113), Beijing, China."
Declaration of interest: Quote: "The author(s) have no proprietary or commercial interest in any materials discussed in this article." Date study conducted: September 2009 to April 2012 Trial registration number: NCT01048476 (registered retrospectively) and NCT10528605 (registered retrospectively) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization sequence with stratification by baseline macular pigment optical density (MPOD) was computer generated, using a permuted block design with block size of 8." |
Allocation concealment (selection bias) | Low risk | Quote: "All participants, the study investigators, and data analysts were masked to treatment assignment." |
Blinding of participants and personnel (performance bias) Visual acuity | Low risk | Quote: "All participants, the study investigators, and data analysts were masked to treatment assignment." Quote: "To protect the blinding, the different capsules were indistinguishable by size, weight, or color." |
Blinding of participants and personnel (performance bias) Progression AMD | Low risk | Quote: "All participants, the study investigators, and data analysts were masked to treatment assignment." Quote: "To protect the blinding, the different capsules were indistinguishable by size, weight, or color." |
Blinding of outcome assessment (detection bias) Visual acuity | Low risk | Quote: "All participants, the study investigators, and data analysts were masked to treatment assignment." Quote: "To protect the blinding, the different capsules were indistinguishable by size, weight, or color." |
Blinding of outcome assessment (detection bias) Progression AMD | Low risk | Quote: "All participants, the study investigators, and data analysts were masked to treatment assignment." Quote: "To protect the blinding, the different capsules were indistinguishable by size, weight, or color." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: Only 1/108 participants apparently discontinued treatment and was excluded from the analysis. All other participants were followed up. |
Selective reporting (reporting bias) | High risk | Judgement comment: Trial registered midway through recruitment. Outcome "late AMD" on trials register but not reported because: "... the present study was not powered adequately to detect a reduction in late AMD incidence". Other differences noted between publication and trials register entry ‐ see above. |