Kaiser 1995.
Methods | Parallel group RCT Method of allocation: sponsor prepared coded tablets Masking: participant ‐ yes; provider ‐ yes; outcome ‐ yes Losses to follow‐up: none |
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Participants | Country: Switzerland Number of people randomised: 20 (20 eyes) Number (%) of people followed up: 20 (20 eyes) Average age (range): 73 years (50 to unknown) Percentage women: 74% Ethnic group: not known Baseline visual acuity: not known Comorbidities affecting the eye: not known Percentage current smokers: not known Inclusion criteria:
Exclusion criteria:
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Interventions | Intervention:
Comparator:
Duration: 6 months Similarity between intervention and comparator: not known |
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Outcomes | Primary: not specified Secondary: not specified Outcomes reported:
Follow‐up: 3 and 6 months Eyes: Only 1 eye per person was evaluated. In cases of bilateral AMD, the eye with better visual acuity was selected |
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Notes | Source of funding:not known Declaration of interest: not known Date study conducted: not known Trial registration number: not known |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation not described in the report but through contact with investigator Quote: "The allocation schedule was generated by the company and treatment schedule was concealed from people enrolling patients." |
Allocation concealment (selection bias) | Low risk | Allocation concealment not described in the report but through contact with investigator Quote: "The allocation schedule was generated by the company and treatment schedule was concealed from people enrolling patients." |
Blinding of participants and personnel (performance bias) Visual acuity | Low risk | Study was placebo‐controlled. Placebo not described in the report but investigator reported that: "The placebo was also prepared by the company and tablets resembled the active treatment." |
Blinding of participants and personnel (performance bias) Progression AMD | Low risk | Study was placebo‐controlled. Placebo not described in the report but investigator reported that: "The placebo was also prepared by the company and tablets resembled the active treatment." |
Blinding of outcome assessment (detection bias) Visual acuity | Low risk | Study was placebo‐controlled. Placebo not described in the report but investigator reported that: "The placebo was also prepared by the company and tablets resembled the active treatment." |
Blinding of outcome assessment (detection bias) Progression AMD | Low risk | Study was placebo‐controlled. Placebo not described in the report but investigator reported that: "The placebo was also prepared by the company and tablets resembled the active treatment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20 participants enrolled and 20 followed up |
Selective reporting (reporting bias) | Unclear risk | Difficult to assess with the information available |