Botulinum Toxin for Strabismus Treatment (NCT07180394) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Botulinum Toxin for Strabismus Treatment
Pakistan127 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Age range
1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* Active thyroid eye disease (Graves Disease), inflamed or pre-phthisical eyes, when surgery is not recommended
* Adjunct to surgery for large-angle esotropia or sixth nerve palsy or for large-angle exotropia
* As a muscle sparing option in patients at risk of anterior segment ischemia
Exclusion Criteria:
* Unrealistic expectations
* Neuromuscular disorders: Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis and Eaton-Lambert syndrome
* Pregnancy and breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: Baseline, at 2 weeks post injection, to 1 year post injection
Trial details
NCT IDNCT07180394
SponsorFoundation University Islamabad
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2030-08-30
Contact for this trial
Dr. Sana Nadeem Associate Professor of Ophthalmology, FCPS, Fellowship in Ped Oph