Botulinum Toxin for Strabismus Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorFoundation University Islamabad

About this trial

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.

Eligibility criteria

Qualifiers

Esotropia or exotropia presenting with a small-to-moderate angle deviation (<40 PD)

Acute onset comitant esotropia

Postoperative residual or consecutive strabismus (2-8 weeks postoperatively or later)

Acute paralytic strabismus to alleviate diplopia while the palsy resolves (mainly sixth nerve palsies, sometimes fourth nerve palsy)

Disqualifiers

Unrealistic expectations

Neuromuscular disorders: Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis and Eaton-Lambert syndrome

Pregnancy and breastfeeding

Trial design

Treatments tested in this trial

  • Botox injection into extraocular muscles

Treatment groups

127 Participants
are divided into 1 treatment group