Complications of Preseptal Versus Pretarsal Botulinum Toxin Injection in Benign Essential Blepharospasm: A Randomized Controlled Trial.

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To compare ocular complications and efficacy of preseptal (PST) versus pretarsal (PTS) botulinum toxin type A (BoNT-A) injection in benign essential blepharospasm (BEB).Randomized clinical trial SETTING: University hospital PATIENT: Twenty-four participants with BEB were enrolled during August 2019 to June 2020. All patients and the outcome evaluator were masked to the injection allocation.For each participant, one eye was randomized to receive PST BoNT-A injection and the fellow eye received PTS BoNT-A injection of the same amount from a single investigator. At baseline, 1 and 3 months after the injection, we collected the symptoms of tearing, lagophthalmos, ptosis, and diplopia and measured marginal reflex distance (MRD) 1 (mm), MRD 2 (mm), degree of lagophthalmos (mm), presence of ectropion, entropion, limitation of ocular motility, tear film breakup time (second), Schirmer’s test (mm), ocular surface staining score (Oxford’s scheme), and Jankovic rating scale of both eyes separately.Complications of the injection RESULTS: There were statistically significant higher rate of self-reported lagophthalmos in PTS (n=12, 52.17%) than PST (n=7, 30.43%) BoNT-A injection (P = 0.024), and significant higher estimated measured lagophthalmos in PTS (0.59 mm, 95% CI 0.44-0.72) than in PST (0.26 mm, 95% CI 0.12-0.40) injection at 1 month using interaction model (Bonferroni-corrected p=0.001). No significant difference in the efficacy and other complication outcomes between the injection locations was observed.PTS BoNT-A injection had a higher rate of lagophthalmos than PST BoNT-A injection for BEB.

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Authors: Lalita Sanguandikul, Supanut Apinyawasisuk, Supharat Jariyakosol, Parima Hirunwiwatkul, Yuda Chongpison