Holz 1993.
Methods | Parallel group RCT Method of allocation: not known Masking: participant ‐ yes; provider ‐ yes; outcome ‐ yes Losses to follow‐up: not known |
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Participants | Country: UK Number of people randomised: 58 (eyes not known) Number (%) of people followed up: not known Average age (range): 68 years (55 to 82) Percentage women: not known Ethnic group: not known Baseline visual acuity: not known Comorbidities affecting the eye: not known Percentage current smokers: not known |
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Interventions | Intervention:
Comparator:
Duration: 12 to 24 months Similarity between intervention and comparator: not known |
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Outcomes | Primary: not known Secondary: not known Quote: "Parameters tested included visual acuity, peripheral and macular colour‐contrast‐sensitivity; pattern ERG and dark adaptation. Stereo fundus photographs and fluorescein angiograms were analyzed by investigators in a masked fashion using a standardized grading scheme" Follow‐up: 12 to 24 months Eyes: unclear |
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Notes | Data available from abstract only: Source of funding: Gertrud‐Kusen‐Stiftung, Hamburg, grant # Ho92/93‐01‐2 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) | Unclear risk | "randomised double‐blind study" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) Visual acuity | Unclear risk | "randomised double‐blind study" |
Blinding of participants and personnel (performance bias) Progression AMD | Unclear risk | "randomised double‐blind study" |
Blinding of outcome assessment (detection bias) Visual acuity | Unclear risk | "randomised double‐blind study" |
Blinding of outcome assessment (detection bias) Progression AMD | Low risk | "randomised double‐blind study" "Stereo fundus photographs and fluorescein angiograms were analyzed by investigators in a masked fashion using a standardized grading scheme" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | High risk | For visual acuity, trial report states that outcome was analysed but only reports that result was not significant |