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

Design Details

1. Study design

Arms

Arm NameArm Description
A. Latanaprost 0.005% once daily (n=231)
B. Placebo (n=230)

Sample Characteristics

1. N
A. Latanaprost 0.005% once daily (n=231)
B. Placebo (n=230)
Total
2. Baseline population
A. Latanaprost 0.005% once daily (n=231)
B. Placebo (n=230)
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalVision disorderProgression of visual field defects, 24 months
  • All Participants
  • 24 months
CategoricalVision disorderMean intraocular pressure (IOP) reduction from baseline, 24 months
  • All Participants
  • 24 months
ContinuousHarm/adverse eventSerious adverse events
  • All Participants
  • 24 months
ContinuousHarm/adverse eventWithdrawal 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 (Progression of visual field defects, 24 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)
24 months
Reduction
Odds Ratio (OR)
Mean reduction
95% CI low (OR)
Events
95% CI high (OR)
Percentage
p value
Within Arm ComparisonsNet Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)

Vision disorder (Mean intraocular pressure (IOP) reduction from baseline, 24 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)
24 months
Mean reduction
Odds Ratio (OR)
Reduction
95% CI low (OR)
Events
95% CI high (OR)
Percentage
p value
Within Arm ComparisonsNet Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)

Continuous


Harm/adverse event (Serious adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)
24 months
Reduction
Odds Ratio (OR)
Mean reduction
95% CI low (OR)
Events
95% CI high (OR)
Percentage
p value
Within Arm ComparisonsNet Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)

Harm/adverse event (Withdrawal due to adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)
end of study
Reduction
Odds Ratio (OR)
Mean reduction
95% CI low (OR)
Total (N analyzed)
95% CI high (OR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
A. Latanaprost 0.005% once daily (n=231)B. Placebo (n=230)