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. 2017 Jul 30;2017(7):CD000254. doi: 10.1002/14651858.CD000254.pub4

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
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:
  • early AMD defined as the presence of soft drusen, presence of any retinal pigmentary abnormalities in the absence of signs of late AMD, or both), according to the AREDS classification system


Exclusion criteria
  • late AMD or other macular or choroidal disorders (e.g. macular edema, macular holes, central serous chorioretinopathy, or macular epiretinal membrane)

  • demonstrated the presence of significant central lens opacities precluding fundus autofluorescence

  • had an implanted intraocular lens

  • glaucoma

  • unstable chronic illness

  • history of intraocular inflammation

  • ocular trauma

  • laser treatment for retinal diseases

  • retina‐vitreous surgery

  • photodynamic therapy

  • currently taking medications affecting macular function (e.g., chloroquine or oxazepam)

  • consumed dietary supplements containing vitamins or carotenoids within the 6 months before enrolment

Interventions Intervention:
  • lutein 10 mg or lutein 20 mg or lutein 10 mg and zeaxanthin 10 mg (3 groups) (daily)

    • 80 people randomised (eyes unknown)

    • 79 (99%) people followed up (eyes unknown)


Comparator:
  • placebo (daily)

    • 27 people randomised (eyes unknown)

    • 27 (100%) people followed up (eyes unknown)


Duration: 12 months
Similarity between intervention and comparator: unclear, placebo was not described
Outcomes From the published paper:
Primary:
  • macular pigment optical density


Secondary:
  • best‐corrected visual acuity

  • contrast sensitivity

  • photorecovery time

  • Amsler grid testing


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
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)
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.