Botulinum toxin treatment versus conservative management in acute traumatic sixth nerve palsy or paresis

Purpose: Botulinum toxin (BTX), injected into the ipsilateral medial rectus muscle, has been advocated for the management of acute traumatic sixth ner ve palsy or paresis. We conducted a multicenter, nonrandomized, data collec tion study to evaluate recovery rates of patients treated with either conse rvative measures or BTX. Methods: All members of the American Association f or Pediatric Ophthalmology and Strabismus and the North American Neuro-Opht halmology Society were invited to enroll patients with acute traumatic sixt h nerve palsy or paresis during a 2-year period (between March 1996 and Feb ruary 1998), The BTX group was defined as patients who received a BTX injec tion within 3 months of injury. Recovery at 6 months from injury was define d as absence of diplopia in the primary position and a distance esotropia o f no more than 10 PD in the primary position. Nonrecovered patients with le ss than 6 months of follow-up (n = 15) were excluded. Results: Eighty-four eligible patients were enrolled by 46 investigators. Sixty-two patients (74 %) were treated conservatively and 22 (26%) with BTX. Sixty-two patients (7 4%) had unilateral palsy, and 22 (26%) had bilateral palsy. Recovery rates were similar between BTX and conservatively treated patients (overall: 73% vs 71%, P = 1.0; unilateral: 81% vs 83%, P = 1.0; bilateral: 50% vs 38%, P = 0.66, respectively). Conclusions: In this prospective multicenter study o f acute traumatic sixth nerve palsy or paresis, patients treated with eithe r BTX or conservative measures had similar high recovery rates.