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

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
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:
  • people with non serous AMD. All participants had regional atrophy of the pigment epithelium. Corrected visual acuity was between 20/100 and 20/25 with distance correction of less than 4 dioptres.


Exclusion criteria:
  • people with diabetes mellitus, endocrine problems, cardiac dysrhythmia, cardial infarction or hypotension, other ocular disorders

Interventions Intervention:
  • Visaline (Novopharma Cham, Switzerland). Each tablet contains 1.5 mg buphenine HCl, 10 mg beta‐carotene, 10 mg tocopherol acetate and 50 mg ascorbic acid. Participants took 2 tablets in the morning and at night, daily, except for Saturdays and Sundays.

    • 9 people randomised (9 eyes)

    • 9 (100%) people followed up (9 eyes)


Comparator:
  • placebo resembling active treatment prepared by sponsor

    • 11 people randomised (11 eyes)

    • 11 (100%) people followed up (11 eyes)


Duration: 6 months
Similarity between intervention and comparator: not known
Outcomes Primary: not specified
Secondary: not specified
Outcomes reported:
  • distance and near visual acuity

  • intraocular pressure

  • visual fields

  • lens opacity

  • retinal visual acuity

  • colour vision

  • contrast sensitivity


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
Notes Source of funding:not known
Declaration of interest: not known
Date study conducted: not known
Trial registration number: not known
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