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

Design Details

1. Study design

Arms

Arm NameArm Description
A. Dorzolamide 2% every 8 hours for 29 days (n=26)
B. Placebo (n=17) Worse eye comparator

Sample Characteristics

1. N
A. Dorzolamide 2% every 8 hours for 29 days (n=26)
B. Placebo (n=17) Worse eye comparator
Total
2. Baseline population
A. Dorzolamide 2% every 8 hours for 29 days (n=26)
B. Placebo (n=17) Worse eye comparator
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalVision disorderPercent change in mean IOP
  • All Participants
  • end of study
CategoricalHarm/adverse eventDrug-related adverse event
  • 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 (Percent change in mean IOP)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Dorzolamide 2% every 8 hours for 29 days (n=26)B. Placebo (n=17) Worse eye comparator
All Arms (ANOVA)
end of study
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
A. Dorzolamide 2% every 8 hours for 29 days (n=26)B. Placebo (n=17) Worse eye comparator
All Arms (ANOVA)

Harm/adverse event (Drug-related adverse event)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Dorzolamide 2% every 8 hours for 29 days (n=26)B. Placebo (n=17) Worse eye comparator
end of study
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
A. Dorzolamide 2% every 8 hours for 29 days (n=26)B. Placebo (n=17) Worse eye comparator