Study |
Bias |
Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Subgroup 1.1.1 Degree of esotropia ≤ 60 prism diopters at baseline |
Mayet 2021 |
High risk of bias |
Baseline characteristics were comparable between intervention groups, but the sequence to allocate the participants was generated by odd or even numbers. |
Some concerns |
The study was described as "unblinded study" in which study personnel and participants could not be masked due to the nature of intervention. Data analysis was restricted to children who were followed up for at least 24 weeks after the last procedure. |
High risk of bias |
The outcome data for one participant (1.8%) in the BNT arm and eight participants in the surgery arm (14.5%) were not included in the final analyses. The reasons of lost to follow‐up or exclusion were not fully described. |
Low risk of bias |
Complete response (i.e. treatment success) was defined as orthophoria or residual esotropia of ≤10 prism diopters. Although the article failed to describe if outcome assessors were masked, the outcome data should not be influenced by knowledge of intervention received. |
Some concerns |
Protocol, trial register, or prespecified analysis plan was not publicly available. The study was powered to detect differences in treatment success as planned and reported. Primary outcome of treatment success was consistently reported in Methods and Results. |
High risk of bias |
See the descriptions shown above. |
Subgroup 1.1.2 Degree of esotropia > 60 prism diopters at baseline |
Mayet 2021 |
High risk of bias |
Baseline characteristics were comparable between intervention groups, but the sequence to allocate the participants was generated by odd or even numbers. |
Some concerns |
The study was described as "unblinded study" in which study personnel and participants could not be masked due to the nature of intervention. Data analysis was restricted to children who were followed up for at least 24 weeks after the last procedure. |
High risk of bias |
The outcome data for one participant (1.8%) in the BNT arm and eight participants in the surgery arm (14.5%) were not included in the final analyses. The reasons of lost to follow‐up or exclusion were not fully described. |
Low risk of bias |
Complete response (i.e. treatment success) was defined as orthophoria or residual esotropia of ≤10 prism diopters. Although the article failed to describe if outcome assessors were masked, the outcome data should not be influenced by knowledge of intervention received. |
Some concerns |
Protocol, trial register, or prespecified analysis plan was not publicly available. The study was powered to detect differences in treatment success as planned and reported. Primary outcome of treatment success was consistently reported in Methods and Results. |
High risk of bias |
See the descriptions shown above. |