Status:
NOT_YET_RECRUITING
Botulinum Toxin for Strabismus Treatment
Lead Sponsor:
Foundation University Islamabad
Conditions:
Strabismic Deviation
Strabismus
Eligibility:
All Genders
1+ years
Phase:
NA
Brief 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. Follo...
Detailed Description
Detailed Description: A Strabismus or squint is an ocular condition characterized by misalignment of the eyes. It derived from the Greek word "strabismos" meaning 'to look obliquely'. It can be catego...
Eligibility Criteria
Inclusion
- 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
- Unrealistic expectations
- Neuromuscular disorders: Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis and Eaton-Lambert syndrome
- Pregnancy and breastfeeding
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT07180394
Start Date
September 30 2025
End Date
August 30 2030
Last Update
September 18 2025
Active Locations (1)
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1
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, Punjab Province, Pakistan, 44000