Summary of findings 2. Topical aminocaproic acid compared with placebo for traumatic hyphema.
Topical aminocaproic acid compared with placebo for traumatic hyphema | ||||||
Patient or population: people with traumatic hyphema Settings: hospital Intervention: 25% to 30% aminocaproic acid in gel every 6 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 | Topical aminocaproic acid | |||||
Short‐term visual acuity 20/40 or better ≤ 2 weeks after treatment | 481 per 1000 | 419 per 1000 (226 to 770) | RR 0.87 (0.47 to 1.60) | 51 (1) | ⊕⊕⊝⊝ low1 | Outcome not reported by 1 other study. |
Medium‐term visual acuity 20/40 or better > 2 weeks and ≤ 2 months after treatment | See comment | ‐ | ‐ | ‐ | ‐ | 1 study reported no difference between groups after 2 weeks of follow‐up. |
Long‐term visual acuity 20/40 or better > 2 months after treatment | See comment | ‐ | ‐ | ‐ | ‐ | Outcome not reported. |
Final visual acuity 20/40 or better at resolution of hyphema | See comment | ‐ | ‐ | ‐ | ‐ | Outcome not reported. |
Time to resolution of primary hemorrhage | See comment | ‐ | ‐ | 142 (2) | ⊕⊕⊝⊝ low2,3 | In 1 study, average time to resolution of the hemorrhage was 11.1 days in participants receiving topical aminocaproic acid and 9.3 and 9.5 days in those receiving placebo; in the second study, the authors reported "no difference" in time to resolution between study groups. |
Secondary hemorrhage at any time point | 227 per 1000 | 109 per 1000 (45 to 250) | RR 0.48 (0.20 to 1.10) | 131 (2) | ⊕⊕⊝⊝ low3,4 | |
Adverse effects: systemic hypotension | See comment | ‐ | ‐ | ‐ | ‐ | 1 study reported that 13% of participants in the topical aminocaproic acid group versus 11% of participants in the placebo group had systemic hypotension. |
*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 (‐2). 2Downgraded for inconsistency (large variation in effect estimate across trials) (‐1). 3Downgraded for indirectness (outcome unrelated to visual acuity or possible complications) (‐1). 4Downgraded for imprecision (‐1).