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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Botox injection into extraocular muscles
DrugBotulinum 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.
Treatment groups
127 Participants
are divided into 1 treatment groupGroup A: Botulinum toxin for strabismus treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Strabismus Angle in Prism Diopters (PD) in the Primary Position from the baseline angle at Week 2, Week 6, 3 months, 6 months, 9 months, and 1 year of the first intramuscular botox injection.
Using the prism cover test (PCT), the strabismus angle in the primary position was determined. The mean of the strabismus angle when viewed from a distance of 6 meters and when viewed from a distance of 33 centimetres was used to calculate the strabismus angle. The same afflicted eye (either the left or the right) was used for each participant's examination for the course of the trial. The difference between the values at Week 2, Week 6, 3 months, 6 months, 9 months, and 1 year and baseline, was used to compute the change from Baseline.
Time frame
Baseline, at 2 weeks post injection, to 1 year post injectionSponsors and contacts
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Source ClinicalTrials.gov
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