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NCT Number: NCT07763457

Japanese Strabismus Outcomes Assessment and Research Group Study

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyoto University Graduate School of Medicine

Kyoto, 606-8507, Japan

Location contact

Manabu Miyata, MD, PhD

CONTACT

[email protected]

+81-75-751-3248

Manabu Miyata, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

This retrospective multicenter cohort study collects clinical data from participating academic and high-volume centers in Japan. To minimize chronological bias and maintain feasibility, the observation period depends on the target disease. For common types of strabismus, data extraction is limited to a recent timeframe (e.g., the past 3 years) to avoid the influence of behavioral changes during the coronavirus disease 2019 (COVID-19) pandemic. For rare and complex strabismus, the extraction period extends up to 10 years (from January 2016 to the date of Institutional Review Board approval) to secure an adequate sample size. Statistical analyses will incorporate mixed-effects models to adjust for institutional clustering and differences in patient backgrounds. Missing data will be addressed via multiple imputation before developing prediction models with machine learning algorithms such as random forests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Strabismus surgery

Procedure

Surgical correction of ocular deviation.

Conservative Treatment or Observation

Other

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

Primary outcomes

  1. Success rate of ocular deviation correction and residual deviation angle

    Time frame: 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.

    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.

Secondary outcomes

  1. Recovery of binocular visual function

    Time frame: Through study completion, up to 10 years

    Evaluate binocularity using standardized clinical tests.

  2. Predictive accuracy of the machine learning nomogram

    Time frame: Through study completion, up to 10 years

    Compare the predictive performance of the developed machine learning models against actual surgical outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Manabu Miyata, MD, PhD

CONTACT

[email protected]

+81-75-751-3248

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Official study title

Establishing Real-World Evidence in Japanese Strabismus Care Through a Multicenter Study: Japanese Strabismus Outcomes Assessment and Research (J-SOAR) Group Study

Acronym: J-SOAR

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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