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Randomized Controlled Trial
. 2021 Nov;35(11):3071-3076.
doi: 10.1038/s41433-020-01300-4. Epub 2021 Jan 11.

Botulinum neurotoxin injections in essential infantile esotropia-a comparative study with surgery in large-angle deviations

Affiliations
Randomized Controlled Trial

Botulinum neurotoxin injections in essential infantile esotropia-a comparative study with surgery in large-angle deviations

I Mayet et al. Eye (Lond). 2021 Nov.

Abstract

Purpose: To compare botulinum neurotoxin (BNT) injections to surgery as first-line therapy in large-angle essential infantile esotropia (IE).

Patients and methods: Children between the ages 6 months and 6 years with IE of ≥40 prism dioptres (PD) were randomised to either a maximum of three BNT injections or surgical intervention of bimedial rectus muscle recession for angles ≤60 PD and augmented with BNT injection in angles >60 PD. Time taken for each procedure was documented. Orthophoria or misalignment of ≤10 PD was regarded as a complete response (CR). Follow-up visits were done at 3, 6, 12 and 24 weeks.

Results: Mean (SD) age and baseline angle of esotropia were 26.9 (14.5) months and 61.9 PD (12.8), respectively, for the overall cohort. The proportion of children who achieved CR was significantly higher in the surgery arm compared to the BNT injection arm (OR = 4.01, 95% CI 1.74-9.22) but the time taken was six times longer (p < 0.0001). In the BNT arm, 55.2% of children aged ≤24 months and 16% of children >24 months achieved CR. In children with esotropia ≤60 PD, CR was achieved in 50% while those with esotropia >60 PD CR was achieved in 25%.

Conclusion: Surgery remains the gold standard for treatment of esotropia but BNT injection is a safe and effective alternative in children ≤24 m and with smaller angles of esotropia ≤60 PD in resource-limited centres.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1. Schematic flow diagram of study patients.
BNT botulinum neurotoxin, CR complete response, NR no response.
Fig. 2
Fig. 2
a Receiver Operating characteristic curves (ROC) for initial angle as a predictor for success. b ROC curve for age as a predictor for success. Orange dot= Youden index.

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