Summary of findings for the main comparison. Systemic aminocaproic acid compared with placebo for traumatic hyphema.
| Systemic aminocaproic acid compared with placebo for traumatic hyphema | ||||||
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Patient or population: people with traumatic hyphema Settings: hospital Intervention: 100 mg aminocaproic acid every 4 hours Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Systemic aminocaproic acid | |||||
| Short‐term visual acuity 20/40 or better ≤ 2 weeks after treatment |
769 per 1000 |
699 per 1000 (438 to 1015) |
RR 0.87 (0.57 to 1.32) | 34 (1) | ⊕⊕⊝⊝ low1,2 | Outcome not reported by 5 other studies. |
| Medium‐term visual acuity 20/40 or better > 2 weeks and ≤ 2 months after treatment | See comment | ‐ | ‐ | ‐ | ‐ | Outcome not reported. |
| Long‐term visual acuity 20/40 or better > 2 months after treatment | 731 per 1000 | 752 per 1000 (599 to 942) | RR 1.03 (0.82 to 1.29) | 108 (2) | ⊕⊕⊝⊝ low1,3 | Outcome not reported by 4 other studies. |
| Final visual acuity 20/40 or better at resolution of hyphema | 866 per 1000 | 908 per 1000 (805 to 1021) | RR 1.05 (0.93 to 1.18) | 143 (2) | ⊕⊕⊝⊝ low1,2 | Outcome not reported by 4 other studies. |
| Time to resolution of primary hemorrhage | See comment | ‐ | ‐ | 330 (6) | ⊕⊕⊝⊝ low1,2 | Average time to resolution of the hemorrhage ranged from 4.1 to 6.7 days in participants receiving oral aminocaproic acid and from 2.4 to 6.3 days in participants receiving placebo (data not meta‐analyzable). |
| Secondary hemorrhage at any time point | 148 per 1000 | 42 per 1000 (19 to 89) | RR 0.28 (0.13 to 0.60) | 330 (6) | ⊕⊕⊝⊝ low2,3 | |
| Adverse effects: nausea or vomiting | 17 per 1000 | 148 per 1000 (36 to 612) | RR 8.60 (2.09 to 35.50) | 131 (3) | ⊕⊕⊕⊝ moderate1 | Outcome not reported by 3 other studies. |
| *The basis for the assumed risk is the control group risk across studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: We are very uncertain about the estimate. | ||||||
1Downgraded for imprecision (‐1). 2Downgraded for indirectness (outcome unrelated to visual acuity or possible complications) (‐1). 3Downgraded for inconsistency (large variation in effect estimate across trials) (‐1).