Crouch 1976.
Methods | Study design: Randomized, double‐masked, placebo‐controlled clinical trial. Exclusions after randomization: None. Losses to follow‐up: None. Intention‐to‐treat: All participants were analyzed in the group to which they had been randomly assigned. Sample size calculations: Not reported. |
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Participants | Country: USA. Dates: September 1972 to October 1974. Number randomized: 59. Age: 83% aged 6 to 30 years. Sex: 83% male. Race: 65% black, 35% white. Sickle cell disease: 8/59 (14%) had sickle cell trait. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria:
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Interventions | Treatment (n = 32): Oral aminocaproic acid 100 mg/kg every 4 hours for 5 days. Control (n = 27): Placebo (200 mL of aromatic elixir (5% glucose, water, and ethanol) in 1000 mL sterile water) every 4 hours for 5 days. Treatment for both groups included:
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Outcomes | Primary outcome: Risk of secondary hemorrhage, assessed by daily slit‐lamp exam, and documented by 3 observers. Secondary outcomes:
Follow‐up: 1 week, 1, 2, 3, 6, 12, 18, and 24 months. |
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Notes | Funded by the National Eye Institute, US National Institutes of Health | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants assigned to treatment groups using computerized randomization. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) Participants | Low risk | Authors used a placebo control and stated that the study was double‐masked. |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Low risk | Authors used a placebo control and stated that the study was double‐masked. |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | There were no exclusions or losses to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Incomplete outcome data (attrition bias) Secondary outcomes | Low risk | There were no exclusions or losses to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Selective reporting (reporting bias) | Low risk | Reported results for primary and secondary outcomes |
Other bias | Low risk | No other sources of potential bias were identified. |