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Not yet recruitingNCT07763457J-SOARUpdated Aug 13, 2026

Japanese Strabismus Outcomes Assessment and Research Group Study

An observational study in Strabismus, sponsored by Kyoto University, Graduate School of Medicine. Not yet recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Kyoto University, Graduate School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Strabismus

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Keywords

  • strabismus surgery
  • machine learning
  • nomogram
  • real-world evidence
  • natural history
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In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 96 across 54 observational studies indexed under Strabismus.

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Lead sponsor

Kyoto University, Graduate School of Medicine is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureStrabismus Surgery

    Surgical correction of ocular deviation.

  • OtherConservative Treatment or Observation

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

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What researchers measure

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.

    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.

Secondary outcomes

  1. Recovery of binocular visual function

    Evaluate binocularity using standardized clinical tests.

    Time frame: Through study completion, up to 10 years

  2. Predictive accuracy of the machine learning nomogram

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

    Time frame: Through study completion, up to 10 years

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07763457
Lead sponsor
Kyoto University, Graduate School of Medicine
Responsible party
Manabu Miyata (Junior Associate Professor, Kyoto University, Graduate School of Medicine) — Principal investigator
First posted
Aug 13, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Aug 13, 2026

Study contacts

Manabu Miyata, MD, PhD
Contact
miyatam@kuhp.kyoto-u.ac.jp
+81-75-751-3248

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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