Treatment for functional epiphora with botulinum toxin-A versus lateral tarsal strip in a randomized trial

Abstract

IntroductionTo compare the efficacy of botulinum toxin A (BoNTA) injection into the lacrimal gland versus lateral tarsal strip (LTS) for functional epiphora. MethodsRandomized clinical trial. Sequential, parallel, non-blinded study design. Patients aged 18 years or older with functional epiphora and a minimum score of 3 in Munk Scale (MS) were randomized to BoNTA or LTS group. Changes in Munk scale, Schirmer test (ST) and quality of life (QoL) were assessed at week 6 and during follow-up until week 30. The mean time without epiphora and the adverse events (AE) were recorded. ResultsThe final analysis included 25 patients, 12 (21 eyes) assigned to BoNTA (5U/0.05 mL) and 13 (20 eyes) to LTS. At 6 weeks there was an improvement in the MS in BoNTA versus LTS group (−2.48 vs −1.55, P = .0152) and at 12 weeks (−2.68 vs −1.69, P = .0267). A significant decrease was noted in the ST at week 2, 12 and 30 with BoNTA. The QoL improved after both interventions without statistical significance. The mean duration of effectiveness in BoNTA group was 26.2 weeks (range 7.7–36.6) and in LTS group was 24.8 weeks (range 6.7–37.6), P = .937. The main AE were temporary eyelid ptosis in 25% (3/12) of the BoNTA group and surgical scar discomfort in 23% (3/13) of the LTS groups, P = .722. No AE were classified as severe. ConclusionBoNTA injection into the lacrimal gland is a safe and effective treatment for functional epiphora, with a greater decrease in MS at 6 and 12 weeks compared with LTS.