Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia

NCT06622044 | Recruiting DMC

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

Brief Summary

This is a single-center, randomized controlled clinical trial to compare the effectiveness of vision therapy and prism wearing for the treatment of small-angle acute acquired concomitant esotropia.

Conditions

Esotropia

Keywords

Vision Therapy; Acute Acquired Concomitant Esotropia

Outcome Measures

Primary Outcomes (1)

• Change in deviation angle at distance and near

  the deviation angle measured using the alternate prism cover test

  1 weeks, 4weeks, 12 weeks, 24 weeks

Secondary Outcomes (4)

• Changes in stereopsis

  1 weeks, 4weeks, 12 weeks, 24 weeks

• Changes in accommodation facility

  1 weeks, 4weeks, 12 weeks, 24 weeks

• Changes in accommodation function

  1 weeks, 4weeks, 12 weeks, 24 weeks

• Change in accommodation convergence to accommodation(AC/A) ratio

  1 weeks, 4weeks, 12 weeks, 24 weeks

Study Arms (2)

Vision therapy group

EXPERIMENTAL

Accommodation facility exercises and divergence exercises

Other: Vision therapy group

Prism group

ACTIVE COMPARATOR

wearing prism glasses

Other: Prism

Interventions

Vision therapy group OTHER

accommodation and vergence exercise

Vision therapy group

Prism OTHER

wearing prism glasses

Prism group

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 10-40 years (including 10 years and 40 years);
• Best-corrected visual acuity no worse than 20/20 for both eyes;
• Deviation angle less than 15 prism diopters (including 15 prism diopters);

You may not qualify if:

• Organic eye diseases;
• Lesions of the brain;
• Receiving esotropia therapy(including surgery and prism treatment)
• Devation angle reducing more than 10 prism diopters after refractive correction

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Esotropia

Interventions

PRDM6, protein, mouse

Condition Hierarchy (Ancestors)

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

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: September 28, 2024
• First Posted: October 1, 2024
• Study Start: September 7, 2024
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)