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. 2023 Jan 16;2023(1):CD004917. doi: 10.1002/14651858.CD004917.pub4

NCT03266549.

Study name Botulinum toxin augmented surgery vs conventional surgery in the management of large angle horizontal deviations
Methods Parallel‐group, randomized controlled trial
Participants Inclusion Criteria:
  • Large‐angle concomitant horizontal strabismus (> 50 prism diopters)


Exclusion Criteria:
  • Other neurologic, or developmental disorders

  • Vertical deviation

  • Significant A or V patterns

  • Paralytic or restrictive forms of strabismus

  • History of eye surgery (strabismus or otherwise)

Interventions Intervention: botulinum toxin augmented surgery
  • unilateral recess‐resect procedure, or bilateral rectus muscle recession plus intraoperative injection of 2.5 to 5 units of botulinum toxin A into the recessed muscle


Control: conventional surgery
  • unilateral recess‐resect procedure, bilateral rectus muscle recession, or 3 horizontal rectus muscle surgery according to the type of strabismus and the presence or absence of deep amblyopia. The standard correction tables will be used as a guide for the amount of muscle recession and, or resection.

Outcomes Primary outcomes :
  • Outcomes will be considered successful if the patients had orthotropia ± 10 PD at 1 week after surgery


Secondary outcomes :
  • Incidence of complications: ptosis vertical deviation under‐correction (residual esotropia) overcorrection (consecutive exotropia) at 1 week after surgery

  • Ocular alignment: orthotropia or angle of deviation if present 2 months postoperative

Starting date February 2021
Contact information Sara Alattar, Msc: alattarsara@yahoo.com
Notes