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. 2019 Jan 14;2019(1):CD005431. doi: 10.1002/14651858.CD005431.pub4

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.
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:

  1. Penetrating injury

  2. Total hyphema

  3. History of a bleeding disorder

  4. Pregnancy
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:

  1. moderate ambulation;

  2. no reading;

  3. head of bed elevated to 45°;

  4. patching of affected eye;

  5. no mydriatics, miotics, corticosteroids, or other topical medication; and

  6. no salicylates.
Outcomes Primary outcome: Risk of secondary hemorrhage, assessed by daily slit‐lamp exam, and documented by 3 observers.
Secondary outcomes:

  1. Time to resolution of primary hemorrhage

  2. Time to secondary hemorrhage

  3. Final VA, with follow‐up ranging between 6 months and 2.5 years

  4. IOP assessed daily by applanation tonometry

  5. Risk of complications and adverse events


Follow‐up: 1 week, 1, 2, 3, 6, 12, 18, and 24 months.
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.