Japanese Strabismus Outcomes Assessment and Research Group Study

NCT07763457 | Not Yet Recruiting

• 2 other identifiers: J-SOAR-202625K12870
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study constructs the largest multicenter registry of strabismus care in Japan. The registry evaluates real-world surgical and conservative treatment outcomes, safety, and natural history for various types of strabismus, including common, rare, and complex cases.

Conditions

Strabismus

Keywords

strabismus surgery; machine learning; nomogram; real-world evidence; natural history

Outcome Measures

Primary Outcomes (1)

• Success rate of ocular deviation correction and residual deviation angle

  Assess the angle of ocular deviation and determine the success rate of clinical management (including observation for natural history, surgical, or conservative treatments) based on established clinical criteria.

  At standard observation intervals (2 to 4 weeks, 3 to 6 months, 1 year, and 2 years post-treatment or baseline) and through study completion, up to 10 years.

Secondary Outcomes (2)

• Recovery of binocular visual function

  Through study completion, up to 10 years

• Predictive accuracy of the machine learning nomogram

  Through study completion, up to 10 years

Study Arms (1)

Strabismus Cohort

Patients diagnosed with strabismus who underwent clinical evaluation or management (including observation for natural history, conservative treatment, or surgery) at participating institutions.

Procedure: Strabismus Surgery; Other: Conservative Treatment or Observation

Interventions

Strabismus Surgery PROCEDURE

Surgical correction of ocular deviation.

Strabismus Cohort

Conservative Treatment or Observation OTHER

Non-surgical management, including clinical observation for natural history, prism therapy, or orthoptic treatment.

Strabismus Cohort

Eligibility Criteria

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

Study Population

Patients diagnosed with strabismus who visited participating academic and high-volume eye centers in Japan for clinical evaluation, conservative treatment, or surgery.

You may qualify if:

• Patients diagnosed with strabismus who underwent clinical evaluation or management (including observation for natural history, conservative treatment, or surgery) at participating institutions.
• Observation period for common strabismus: A restricted recent timeframe (e.g., the most recent 3 years) to minimize selection bias.
• Observation period for rare and complex strabismus: Up to 10 years (January 1, 2016, to the date of Institutional Review Board approval) to secure an adequate sample size.

You may not qualify if:

• Patients who formally opted out of data utilization for this study.

Sponsors & Collaborators

• Kyoto University, Graduate School of Medicine: lead

Study Sites (1)

Kyoto University Graduate School of Medicine

Kyoto, Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Strabismus

Interventions

Conservative Treatment; Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Methods; Investigative Techniques

Central Study Contacts

Manabu Miyata, MD, PhD

CONTACT

+81-75-751-3248; miyatam@kuhp.kyoto-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Associate Professor

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)