Summary of findings 1. Surgery versus botulinum neurotoxin injections.
| Surgery compared with botulinum toxin injections in children with infantile esotropia | ||||||
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Patient or population: children with infantile esotropia Settings: tertiary care, single center Intervention: surgery Comparison: botulinum toxin injections | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Botulinum toxin injections | Surgery | |||||
| Treatment success: improvement in the angle of strabismus at 6 months | 370 per 1000 | 696 per 1000 (470 to 1000) |
RR 1.88 (95%CI 1.27 to 2.77) |
101 (1) |
⊕⊝⊝⊝ Very lowa,b | 23 children (48.9%) in the surgery arm, who had > 60 prism diopters at baseline, also received botulinum toxin intraoperatively. |
| Presence and quality of binocularity at 6 months | No outcome data available for this outcome | ‐ | ‐ | ‐ | ||
| Adverse effects (severe, minor) in 6 months | See comments | 101 (1) |
⊕⊝⊝⊝ Very lowa,b | Reported in botulinum toxin arm: partial transient ptosis in 9 (16.7%) children, transient vertical deviation in 3 (5.6%) children, and consecutive exotropia in 13 (24.1%) children | ||
| *The assumed risk is based on the estimate (proportion of participants with the case) in the control group. The corresponding risk (and its 95% confidence interval) 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 | ||||||
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GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded one level for study limitations due to high risk of bias in the randomization process, deviations from intended interventions, and missing outcome data bDowngraded two levels for imprecision of results