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Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Horizontal Deviations

NCT03266549 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-02-21

No results posted yet for this study

Summary

Horizontal strabismus includes esotropia and exotropia where there is inward or outward deviation of visual axes of the eyes respectively. The most common initial treatment of horizontal strabismus is either bilateral rectus muscle recessions or unilateral recession resection surgery. For large angle deviations (\>50 prism diopters \[PD\]), surgery on 2 muscles alone may not be adequate with high reoperation rates. Approaches to these patients included large bilateral muscle recessions, supramaximal unilateral recession resection procedure, three or four horizontal muscle surgery, or botulinum toxin augmented surgery.

Botulinum toxin augmentated strabismus surgery was reported in several studies. Owens et al.reported successful botulinum toxin augmentation of monocular recession-resection surgeries in 3 large-angle exotropia patients with successful results in two of the 3 patients. Khan reported 8 patients with \> 60 PD esotropia treated with botulinum-augmented surgery. Six of 8 had deviations of 10 PD or less following surgery. Özkan et al used botulinum augmentation in a group of older patients with large angle esotropia of different etiologies, with a success rate of 57%. Lueder et al evaluated the long-term outcomes in patients with infantile esotropia. The results were good, with a 74% success rate. Based on historical comparisons, this technique appears equally as effective as 3- or 4-muscle surgery and more effective than large bilateral medial rectus recessions alone.

Ideally, a prospective randomized study should be performed to more definitively determine the effectiveness of intraoperative botulinum toxin augmentation compared to surgery alone.

Conditions

  • Large Angle Horizontal Strabismus

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • sara Alattar · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-20
Primary Completion
2021-08-31
Completion
2021-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03266549 on ClinicalTrials.gov