Botulinum Toxin Injection Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia

NCT06714877 | Not Yet Recruiting

• 1 other identifier: 2024-BTXAACE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, randomized controlled trial evaluating type A botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia. Specific Aim 1 (Primary): To compare the reduction of deviation angle and improvement of diplopia symptoms between botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia. Specific Aim 2 (Secondary): To compare the improvement of visual functions between botulinum toxin injection and prism therapy for the treatment of small-angle acute acquired concomitant esotropia.

Conditions

Esotropia

Keywords

Acute Acquired Concomitant Esotropia; Treatment; Botulinum Toxin Injection

Outcome Measures

Primary Outcomes (1)

• strabismus angle

  using prism cover test to evaluate the reduction of strabismus angle

  Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

Secondary Outcomes (1)

• stereopsis

  Before treatment, 1 week, 1 month, 3 months, 6 months after treatment

Study Arms (2)

prism treatment group

ACTIVE COMPARATOR

prism treatment

Other: prism treatment group

botulinum toxin group

EXPERIMENTAL

botulinum toxin injection

Procedure: botulinum toxin group

Interventions

prism treatment group OTHER

wearing prism glasses

prism treatment group

botulinum toxin group PROCEDURE

botulinum toxin injection

botulinum toxin group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• acute acquired concomitant esotropia diagnosis (sudden onset of esotropia or diplopia, no significant change in the degree of strabismus in each eye position, and no limitation in eye movement)
• strabismus angle ≤ 25PD
• best corrected visual acuity of both eyes ≥ 1.0
• intracranial disease is excluded by cranial CT or magnetic resonance imaging

You may not qualify if:

• reduction of strabismus angle by more than 10 prism diopters after refractive correction
• history of other ocular diseases or ocular surgeries
• presence of organic brain lesions or systemic diseases

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China, China

Location

MeSH Terms

Conditions

Esotropia

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Wen Wen, MD, PhD

  Eye & ENT Hospital of Fudan University, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Wen Wen, MD, PhD

CONTACT

+86 (21) 3423 3133; wenweneye@126.com

Shuyang Guo, MD

CONTACT

m15880091363@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 4, 2024
• Study Start: December 10, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 10, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)