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

Crouch 1997.

Methods Study design: Randomized, double‐masked clinical trial.
Exclusions after randomization: 1 individual assigned to oral aminocaproic acid and topical placebo excluded due to side effect of drug (vomiting).
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: Sample size was determined to be 25 to 30 participants in each of the 3 groups based on alpha of 0.05 and power of 80%.
Additional comments: The investigators also studied a control group that did not receive either topical or systemic aminocaproic acid and had refused randomization. We did not include these individuals in our analyses.
Participants Country: USA.
Dates: March 1990 to May 1996.
Number randomized: 64: 29 to oral aminocaproic acid plus topical placebo, 35 to oral placebo plus topical aminocaproic acid. Additional 54 participants included as control group.
Age: 72% younger than 21 years.
Sex: 67% male.
Race: 50% black, 49% white, and 1% (1 participant) Asian.
Sickle cell disease: 2/35 (6%) of participants assigned to topical aminocaproic acid, and 2/29 (7%) of participants assigned to oral aminocaproic acid had sickle cell trait.
Participants appeared to be balanced with respect to baseline characteristics.
Inclusion criteria: Traumatic hyphema.
Exclusion criteria:

  1. Penetrating ocular injury

  2. History of anticoagulant or antiplatelet agent within 7 days of ocular trauma

  3. Oral or topical corticosteroid use within 48 hours of study

  4. History of a coagulopathy

  5. History of renal or hepatic insufficiency

  6. Previous intraocular surgery

  7. History of sensitivity to any component of topical aminocaproic acid

  8. Pregnancy

  9. Participation in any investigational drug trial within last 4 weeks
Interventions Treatment: 0.2 mL of 30% aminocaproic acid in 2% carboxymethylene gel applied to inferior fornix every 6 hours plus oral placebo solution every 4 hours for 5 days.
Control: Oral aminocaproic acid 50 mg/kg (up to 30 g/day) plus placebo gel every 4 hours for 5 days.
Treatment for both groups included:

  1. moderate ambulation;

  2. head of bed elevated to 30°;

  3. shield on affected eye;

  4. no aspirin, corticosteroids, non‐steroidal anti‐inflammatory, or antiplatelet agents; and

  5. topical timolol maleate, apraclonidine hydrochloride, dipivefrine hydrochloride, or oral acetazolamide if IOP > 22 mmHg.
Outcomes Primary outcome: Risk of secondary hemorrhage, assessed by daily slit‐lamp exam, and documented by a sketch each day.
Secondary outcomes:

  1. VA, measured daily and at the end of the 5 days (final VA)

  2. Cell and flare, assessed daily for 5 days

  3. Corneal blood staining and toxicity, assessed daily by slit‐lamp exam for 5 days

  4. IOP assessed daily for 5 days by applanation tonometry

  5. Risk of complications and adverse events
Notes Funded in part by the Lions Medical Eye Bank and Research Center of Eastern Virginia
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. Placebo pills were given to the topical group and placebo gel administered to the systemic group to make both regimens similar.
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. "Data were compiled by observers who did not know what patients were in the treated and untreated control groups."
Incomplete outcome data (attrition bias) 
 Primary outcome Unclear risk 1 participant who was assigned to oral aminocaproic acid and topical placebo was excluded due to side effect of drug (vomiting). The remaining participants were analyzed in the group to which they had been randomly assigned.
Incomplete outcome data (attrition bias) 
 Secondary outcomes Unclear risk 1 participant who was assigned to oral aminocaproic acid and topical placebo was excluded due to side effect of drug (vomiting). The remaining 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.