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. |
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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:
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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:
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Outcomes | Primary outcome: Risk of secondary hemorrhage, assessed by daily slit‐lamp exam, and documented by a sketch each day. Secondary outcomes:
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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. |