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

McGetrick 1983.

Methods Study design: Randomized, double‐masked clinical trial.
Exclusions after randomization: The chart of 1 participant in the placebo group was "lost," and this participant was excluded.
Losses to follow‐up: None.
Intention‐to‐treat: The excluded participant was not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses.
Sample size calculations: Not reported.
Participants Country: USA.
Dates: August 1980 to February 1982.
Number randomized: 50: 28 to aminocaproic acid, 22 to placebo.
Age: 86% aged 6 to 40 years.
Sex: 81% male.
Race: 69% black, 21% Hispanic, and 10% white.
Sickle cell disease: None; excluded.
Participants appeared to be balanced with respect to baseline characteristics.
Inclusion criteria: Non‐penetrating traumatic hyphema.
Exclusion criteria:

  1. Penetrating ocular injury

  2. Requirement for immediate surgical intervention

  3. Sickle cell hemoglobin

  4. History of intravascular coagulopathy

  5. Pregnancy
Interventions Treatment: Oral aminocaproic acid 100 mg/kg (up to 5 g/dose and 30 g/day) every 4 hours, for 5 days.
Control: Placebo every 4 hours for 5 days.
Treatment for both groups included:

  1. quiet activities;

  2. no reading;

  3. patch and shield on affected eye;

  4. topical 1% atropine sulfate 4 times/day;

  5. oral paracetamol up to 650 mg/day;

  6. no aspirin; and

  7. topical timolol maleate 0.25% or 0.5% and oral acetazolamide, if IOP > 35 mmHg.
Outcomes Primary outcome: Risk of secondary hemorrhage, assessed daily by slit‐lamp exam. Defined as a definite increase in the amount of blood in the anterior chamber following admission.
Secondary outcomes:

  1. Time to resolution of primary hemorrhage

  2. Time to secondary hemorrhage

  3. VA (final) with follow‐up ranging from 0 to 9 months

  4. IOP assessed daily by applanation tonometry for 5 days

  5. Length of hospitalization

  6. Risk of complications and adverse events
Notes Funded by the National Eye Institute, National Institutes of Health, Bethesda, MD and Research to Prevent Blindness, Inc
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were 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. Assignment codes were not broken until the study was terminated.
Incomplete outcome data (attrition bias) 
 Primary outcome Unclear risk The chart of 1 participant in the placebo group was "lost," and this participant was excluded. The excluded participant was not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses.
Incomplete outcome data (attrition bias) 
 Secondary outcomes Unclear risk The chart of 1 participant in the placebo group was "lost," and this participant was excluded. The excluded participant was not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses.
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.