Short-term outcome of botulinum neurotoxin A injection with or without sodium hyaluronate in the treatment of infantile esotropia—a prospective interventional study

Abstract

Purpose: To compare the short-term outcome of botulinum neurotoxin A (BoNT-A) with or without sodium hyaluronate in the treatment of infantile esotropia (IE). Methods: In this tertiary care hospital-based prospective, interventional, non-randomized study on infants with IE below one year of age, 25 cases were enrolled in the sodium hyaluronate (SH) group to receive 2.5 U BoNT-A injection combined with SH in each medial rectus muscle (MR). Thirty patients were enrolled in the control group to receive 2.5 U BoNT-A injection with normal saline in each MR. The change in mean primary ocular deviation (POD) and complications were assessed at 2 weeks, 1 month, 3 months, and 6 months post injection. Mann–Whitney U test was used for non-parametric unpaired data. Chi-square test and Fisher's exact test were used to test for the strength of the association between the two categorical variables. Results: Satisfactory ocular alignment was achieved in 76% in SH group and 73% in the control group ( P value = 0.80). While the change in mean POD was comparable (29.2 prism diopters [PD] vs 29.3 PD; P value = 0.65), the complication rates were significantly lesser in SH (16% vs 33.3%; P value = 0.14). Conclusion: BoNT-A combined with SH is equally effective with lesser complications as compared to botulinum toxin alone in the treatment of IE.

Response to comments on

“…[ 1 ] Our study was conducted to assess the effect of combining Botulinum neurotoxin A (BoNT –A) with Sodium Hyaluronate (SH) in Indian children below 1 year with a simpler technique of preparation of injection. [ 2 ] The concentration of SH was same as used by Chen et al [ 3 ] We have demonstrated similar effectivity and address the concerns raised by the authors here.…”

Journey of a therapeutic poison: Botulinum toxin A and its biosimilars

“…Pandey et al . [ 9 ] have successfully used this product for infantile esotropia. The authors of the present study in this journal issue have described their experience with the same product in the treatment of essential blepharospasm and hemifacial spasms.…”

Comments on

“…Pandey N and colleagues need to be commended for replicating, in Indian population, the study comparing outcomes of botulinum neurotoxin A injection with and without sodium hyaluronate (SH) in treating infantile esotropia (IET). [ 1 ] We would like to make certain observations. Chen and colleagues describe constitution of toxin-SH done at 4°C.…”