Tratamiento de la epífora funcional con toxina botulínica tipo A frente a la tira tarsal en un ensayo aleatorizado / Treatment for functional epiphora with botulinum toxin-A versus lateral tarsal strip in a randomized trial

Objetivo Comparar la eficacia de la inyección de toxina botulínica A (TBA) en la glándula lagrimal con la tira tarsal lateral (TTL) en la epífora funcional. Material y método Ensayo clínico aleatorizado. Diseño secuencial, paralelo y no ciego. Pacientes de 18 años o más con epífora funcional con un mínimo de 3 en la escala de Munk (EM) se incluyeron a grupo de TBA o TTL. Los cambios en la EM, el test de Schirmer y la calidad de vida se evaluaron a la semana 6 y hasta la semana 30. Se obtuvo el tiempo medio sin epífora y los acontecimientos adversos. Resultados El análisis final incluyó 25 pacientes, 12 (21 ojos) se asignaron a TBA (5U/0,05mL) y 13 (20 ojos) a TTL. A la semana 6 hubo un mayor descenso en la EM en el grupo de TBA frente a TTL (−2.48 vs. −1.55, p=0,0152) y a la semana 12 (−2,68 vs. −1,69, p=0,0267). Se observó un descenso significativo en el test de Shirmer a las semanas 2, 12 y 30 con TBA. La calidad de vida mejoró después de ambas intervenciones, sin diferencias significativas. El tiempo medio sin epífora en el grupo TBA fue de 26,2 semanas (7,7-36,6) y en el grupo TTL de 24,8 semanas (6,7-37,6), p=0,9368. Se observó ptosis temporal en un 25% (3/12) en el grupo TBA y un 23% (3/13) de molestias de la cicatriz quirúrgica en el grupo TTL, p=0,722. Ningún acontecimiento adverso fue severo. Conclusión La inyección de TBA en la glándula lagrimal es efectiva y segura en el tratamiento de la epífora funcional, con mayor descenso en la EM a las 6 y 12 semanas comparado con la TTL (AU)

Objective To compare the efficacy of botulinum toxin A (BoNTA) injection into the lacrimal gland versus lateral tarsal strip (LTS) for functional epiphora Material and methods Randomized 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 MS, Schirmer test and quality of life were assessed at week 6 and during follow-up until week 30. The mean time without epiphora and the adverse events were recorded. Results The final analysis included 25 patients, 12 (21 eyes) assigned to BoNTA (5U/0.05mL) 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 Schirmer test at week 2, 12 and 30 with BoNTA. The quality of life 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=.9368. The main adverse events were temporary eyelid ptosis in 25% (3/12) of the BoNTA group and surgical scar discomfort in 23% (3/13) of the LTS group, P=.722. No adverse events were classified as severe. Conclusion BoNTA 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 (AU)

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

INTRODUCTION: To compare the efficacy of botulinum toxin A (BoNTA) injection into the lacrimal gland versus lateral tarsal strip (LTS) for functional epiphora. METHODS: Randomized 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. RESULTS: The 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. CONCLUSION: BoNTA 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.