StrabismusJ-SOARNCT07763457
Japanese Strabismus Outcomes Assessment and Research Group Study
An observational study of Strabismus, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Strabismus
- What is being tested?
- Strabismus Surgery and Conservative Treatment or Observation
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2026to 31 Dec 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with strabismus who visited participating academic and high-volume eye centers in Japan for clinical evaluation, conservative treatment, or surgery.
Who may be able to join
- 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.
Who cannot join
- Patients who formally opted out of data utilization for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site
Kyoto University Graduate School of Medicine
Kyoto, Kyoto, 606-8507
Manabu Miyata, MD, PhD, +81-75-751-3248, miyatam@kuhp.kyoto-u.ac.jp
Manabu Miyata, MD, PhD
About this study
Official title: Establishing Real-World Evidence in Japanese Strabismus Care Through a Multicenter Study: Japanese Strabismus Outcomes Assessment and Research (J-SOAR) 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.
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.
- Conditions
- Strabismus
- Being tested
- Strabismus Surgery, Conservative Treatment or Observation
- Keywords
- strabismus surgery, machine learning, nomogram, real-world evidence, natural history
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strabismus SurgeryProcedure or surgery
Surgical correction of ocular deviation.
Conservative Treatment or ObservationOther
Non-surgical management, including clinical observation for natural history, prism therapy, or orthoptic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Strabismus Cohort | Patients diagnosed with strabismus who underwent clinical evaluation or management (including observation for natural history, conservative treatment, or surgery) at participating institutions. Receives: Procedure: Strabismus Surgery; Other: Conservative Treatment or Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Evaluate binocularity using standardized clinical tests.
Measured: Through study completion, up to 10 years
Predictive accuracy of the machine learning nomogram
Compare the predictive performance of the developed machine learning models against actual surgical outcomes.
Measured: Through study completion, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manabu Miyata, Kyoto University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763457
- Sponsor's protocol ID
- J-SOAR-2026
- Other IDs
- 25K12870
- Acronym
- J-SOAR
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No