Extraction form for project: Screening for Glaucoma in Adults - 1 of 2

Design Details

1. Study design

Arms

Arm NameArm Description
A. Levobunolol 0.5% twice daily (n=14)
B. Levobunolol 1.0% twice daily (n=13)
C. Placebo (n=15)

Sample Characteristics

1. N
A. Levobunolol 0.5% twice daily (n=14)
B. Levobunolol 1.0% twice daily (n=13)
C. Placebo (n=15)
Total
2. Baseline population
A. Levobunolol 0.5% twice daily (n=14)
B. Levobunolol 1.0% twice daily (n=13)
C. Placebo (n=15)
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalVision disorderOverall mean change during study
  • All Participants
  • end of study
ContinuousQuality of lifeWithdrawal due to adverse events
  • All Participants
  • end of study

Risk of Bias Assessment

1. Random assignment
2. Allocation concealed
3. Groups similar at baseline
4. Eligibility criteria specified
5. Blinding: outcome assessors or data analysts
6. Intention-to-treat analysis
7. Reporting of attrition, contamination, etc.
8. Differential loss to followup or overall high loss to followup
9. Appropriate analysis including cluster correlation
10. Funding source
11. Randomization adequate?
12. Allocation concealment adequate?
13. Groups similar at baseline?
14. Eligibility criteria specified?
15. Outcome assessors masked?
16. Care provider masked?
17. Patient masked?
18. Attrition and withdrawals reported?
19. Loss to followup differential/ high?
20. People analyzed in the groups in which they were randomized?
21. Quality

Results

Categorical


Vision disorder (Overall mean change during study)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Levobunolol 0.5% twice daily (n=14)B. Levobunolol 1.0% twice daily (n=13)C. Placebo (n=15)
vs.
end of study
Mean change
p value
Percentage
Within Arm ComparisonsNet Comparisons
A. Levobunolol 0.5% twice daily (n=14)B. Levobunolol 1.0% twice daily (n=13)C. Placebo (n=15)
vs.

Continuous


Quality of life (Withdrawal due to adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Levobunolol 0.5% twice daily (n=14)B. Levobunolol 1.0% twice daily (n=13)C. Placebo (n=15)
end of study
Percentage
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
A. Levobunolol 0.5% twice daily (n=14)B. Levobunolol 1.0% twice daily (n=13)C. Placebo (n=15)