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Vision Therapy Combined with Botulinum Toxin Type A Versus Botulinum Toxin Type A Alone for Acute Acquired Comitant Esotropia: A Randomized Controlled Trial

Vision Therapy Combined with Botulinum Toxin Type A Versus Botulinum Toxin Type A Alone for Acute Acquired Comitant Esotropia: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127043
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-06-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Acute Acquired Comitant Esotropia

Interventions

Control Group:Botulinum toxin type A injection therapy
Experimental Group:Botulinum toxin type A injection combined with comprehensive vision function training

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 35 years old; 2.Acute onset of esotropia with diplopia or visual confusion; 3.Difference in strabismic angle across different gaze directions <= 5 prism diopters (?); 4.Essentially normal ocular motility in all directions; 5.Distance and near strabismic angles measured by prism and alternate cover test (PACT) both <=25?; 6.Willing to sign the informed consent form voluntarily and to complete follow-up visits and relevant examinations as per the study protocol; 7.Female participants of childbearing age must agree to take strict and effective contraceptive measures during the study period.

Exclusion criteria

Exclusion criteria: 1.Best corrected visual acuity 1.5D with reduction of strabismic angle >= 10? after full correction; 4.Active ocular infection or intraocular inflammation; 5.Prior orbital CT showing abnormality or displacement of extraocular muscles; 6.History of ocular surgery or previous botulinum toxin injection for strabismus; 7.Neuromuscular disorders; 8.Use of medications affecting neuromuscular junction; 9.Poorly controlled hypertension or diabetes mellitus; 10.Bleeding disorders or use of anticoagulant/antiplatelet medications; 11.Pregnant or lactating women, or those planning pregnancy during the treatment/follow-up period; 12.Severe mental illness or cognitive impairment that prevents understanding or compliance with treatment and follow-up; 13.Known allergy to botulinum toxin or any component of the formulation.

Design outcomes

Primary

MeasureTime frame
Functional Cure Rate;

Secondary

MeasureTime frame
Clinical measures;Adverse reactions related to botulinum toxin injection;Adult Strabismus-20, AS-20;Adverse reactions related to vision function training;Clinical cure;

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: Jul 3, 2026