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Botulinum Toxin for Strabismus Treatment

NCT07180394 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-09-18

No results posted yet for this study

Summary

The bacterial species Clostridium botulinum produces a class of neurotoxins known as botulinum toxin. At the neuromuscular junction, botulinum toxin A prevents acetylcholine from being released. Following a Botox intramuscular injection, the injected EOM becomes paralysed 2-4 days after the injection and remains so clinically for at least 5-8 weeks. Muscle function recovery takes five to fourteen weeks, depending on the injection site, volume, and concentration of the solution, as well as the innervation density.

Botulinum toxin treatment results in a pharmacologic recession of the injected extraocular muscle, and the muscle lengthens while its agonist contracts, paralysing it. Improved ocular alignment or a decrease in the severity of the deviation may last for a long time, even if the pharmaceutical impact normally goes away after three months.

Even after the pharmacologic effect has worn off, a number of elements, such as mechanical, proprioceptive, and binocular effects, may intervene during the period of muscle paralysis to help stabilise and improve alignment in strabismus patients over the long term.

Conditions

  • Strabismic Deviation
  • Strabismus

Interventions

DRUG

Botox injection into extraocular muscles

Botulinum toxin in various doses by injecting it into the overacting extraocular musces in strabismus patients, especially pediatric, but also adult cases, to use it as an alternative for strabismus surgery. For children, it will be administered under sedation or general anesthesia and in adults, under topical anesthesia. The pre-operative measurements of the type of strabismus, patterns, deviation, and post-operative results will be studied both in the short and long-term.

Sponsors & Collaborators

  • Foundation University Islamabad

    lead OTHER

Principal Investigators

  • Dr. Sana Nadeem Assoc. Prof., FCPS · Foundation University Islamabad

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2030-08-30
Completion
2030-08-30

Countries

  • Pakistan

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 NCT07180394 on ClinicalTrials.gov