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Efficacy and Safety of Acupuncture for Refractory Peripheral Ophthalmoplegia: A Pilot Study for a Prospective, Single-Centre, Randomized, Controlled, Assessor-Blinded Clinical Trial

Efficacy and Safety of Acupuncture for Refractory Peripheral Ophthalmoplegia: A Pilot Study for a Prospective, Single-Centre, Randomized, Controlled, Assessor-Blinded Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002233
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Refractory Peripheral Ophthalmoplegia

Interventions

Control Group:Periocular injection

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Peripheral Ophthalmoplegia by an ophthalmologist. 2. Aged 18 to 80 years, inclusive. 3. Symptoms refractory to conventional therapy (e.g., oral vitamins, hormones, vasodilators, or injections) for over 1 month. 4. Mentally competent, cooperative, and with stable vital signs. 5. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Congenital Ophthalmoplegia, Chronic Progressive Ophthalmoplegia, central ophthalmoplegia, or painful ophthalmoplegia; history of extraocular muscle surgery. 2. Etiology due to intracranial/orbital mass or Myasthenia Gravis. 3. Any clinically significant untreated or unstable condition identified prior to screening. 4. Previous neurosurgical intervention or unresolved head trauma. 5. Contraindications to acupuncture (e.g., bleeding tendency, coagulopathy, local skin infection/ulceration/scarring). 6. Inability to complete synoptophore examination due to nystagmus or abnormal retinal correspondence. 7. History of allergic reaction to mecobalamin, Ginkgo biloba tablets, or Compound Anisodine Hydrobromide Injection. 8. Contraindications to MRI (e.g., metallic implants, claustrophobia). 9. Inability to cooperate with study procedures or complete the treatment course. 10. Pregnancy, lactation, or women of childbearing potential not using contraception. 11. Concurrent participation in another clinical trial. 12. Any other condition deemed by the researcher to compromise subject safety or study validity.

Design outcomes

Primary

MeasureTime frame
The maximum degree of the nine positions on the Synoptophore.;

Secondary

MeasureTime frame
Synoptophore Grade I Visual Function;Synoptophore Fusion Range;Synoptophore Stereoscopic Vision;Berke Muscle Strength Evaluation Method;pupil size;Diplopia Symptom Rating Scale;Patient Health Questionnaire-9 items, PHQ-9;Generalized Anxiety Disorder-7, GAD-7;

Countries

China

Contacts

Public ContactHongyang Li

Beijing Friendship Hospital, Capital Medical University

faraway_sweet@163.com+8613301333869

Outcome results

None listed

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