Summary of findings 1. Botulinum toxin versus surgery.
Botulinum toxin versus surgery in adults and children with strabismus | |||||||
Patient or population: adults and children with strabismus Setting: pediatric ophthalmology clinic, private practice, and university hospital Intervention: botulinum toxin Comparison: surgery | |||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | ||
Risk with surgery | Risk with botulinum toxin | ||||||
Improved or corrected strabismusa at 6 or 12 months | 683 per 1000 | 492 per 1000 (362 to 677) | RR 0.72 (0.53 to 0.99) | 242 (4 RCTs) | ⊕⊕⊝⊝ lowb,c | Subgroup analysis based on age of onset: children ≤ 2 years of age (RR 0.84, 95% CI 0.59 to 1.20; 1 study, 55 participants); children > 2 and < 18 years of age (RR 0.76, 95% CI 0.49 to 1.18; I² = 62%; 2 studies, 157 participants); adults or ≥ 18 years of age (RR 0.38, 95% CI 0.17 to 0.85; 1 study, 30 participants). Subgroup analysis based on duration of follow‐up: 6 months (RR 0.55, 95% CI 0.38 to 0.80; I² = 2%; 2 studies, 140 participants); > 6 months (RR 0.88, 95% CI 0.69 to 1.14; I² = 0%; 2 studies, 102 participants). Sensitivity analysis excluded a study with high risk of bias that was the most weighted study (RR 0.76, 95% CI 0.52 to 1.12; I² = 53%; 3 studies, 132 participants). |
|
Serious adverse events at 6 or 12 months | No outcome data were available for this outcome. | – | – | – | – | ||
Proportion of participants requiring additional surgery(ies) at 6 or 12 months | 128 per 1000 | 389 per 1000 (171 to 882) | RR 3.05 (1.34 to 6.91) | 101 (1 RCT) | ⊕⊝⊝⊝ very lowb,d | – | |
Proportion of participants who achieved binocular single vision at 6 or 12 months | Sensory fusion (positive response with Worths four light test) | 615 per 1000 | 542 per 1000 (388 to 757) | RR 0.88 (0.63 to 1.23) | 102 (2 RCTs) | ⊕⊕⊝⊝ lowb,c | – |
Stereopsis (minimum of 480 seconds of arc) | 558 per 1000 | 480 per 1000 (329 to 697) | RR 0.86 (0.59 to 1.25) | 102 (2 RCTs) | – | ||
Quality of life, as measured by validated instruments | No outcome data were available for this outcome. | – | – | – | – | ||
Non‐serious adverse events at 6 or 12 months | See comments | 212 (3 RCTs) |
⊕⊕⊝⊝ lowa,b | Partial transient ptosis occurred, ranging from 16.7% to 37.0% of children treated with botulinum toxin. Transient vertical deviation was present, ranging from 5.6% to 18.5% of children in the botulinum toxin arm. In one study, 44.7% of children in the surgery arm experienced discomfort on day 1. | |||
*The risk in the intervention group (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). Abbreviations: CI: confidence interval; PD: prism diopters; RCT: randomized controlled trial; RR: risk ratio | |||||||
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. |
aImproved or corrected strabismus, defined as follows:
- orthophoria or orthotropia; or
- residual heterophoria/tropia ≤10 PD or ≤ 5° observed in the cover test at distance and at near; or
- residual heterophoria/tropia ≤10 PD or ≤ 5° observed in the cover test at distance and at near and at least one binocular test.
bDowngraded one level for risk of bias. cDowngraded one level for imprecision of results. dDowngraded two levels for imprecision of results.