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A Randomized Controlled Study of Botulinum Toxin Type A in the Treatment of Acute Acquired Superior Oblique Muscle Palsy

A Randomized Controlled Study of Botulinum Toxin Type A in the Treatment of Acute Acquired Superior Oblique Muscle Palsy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094561
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired superior oblique palsy is an acute unilateral or bilateral dysfunction of the superior oblique muscle caused by various acquired etiologies. Clinically, it is characterized by diplopia (including in primary gaze or reading position) and compensatory head posture.

Interventions

Botulinum toxin injection treatment group:Injection Route: A conjunctival incision is made in the inferotemporal region near the vault of the globe for direct vision injection.
Control group:Neurotrophic medication therapy

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients with a definite diagnosis of acquired superior oblique palsy (if the etiology is clear and the primary condition is stable); 2.Age: 12 to 80 years; 3.Binocular diplopia; 4.Best corrected visual acuity of both eyes = 0.5; 5.Duration of illness < six months; 6.Vertical strabismus = 15 prism diopters (PD); 7.Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Horizontal strabismus =10 PD; 2.Coexisting other extraocular muscle palsies/orbital fractures; 3.History of strabismus or orbital surgeries; 4.History of myasthenia gravis; 5.Acupuncture treatment within one month prior to the therapy; 6.Congenital or decompensated congenital superior oblique palsy; 7.Pregnant women;

Design outcomes

Primary

MeasureTime frame
Cure rate: Vertical strabismus in the primary gaze position = 2 PD, with the disappearance of binocular diplopia in the primary and reading positions.;

Countries

China

Contacts

Public ContactJingchang Chen

The Zhongshan Ophthalmic Center,Sun Yat-sen University

chenjingchang@gzzoc.com+86 20 87330484

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026