Establishing Real-World Evidence in Japanese Strabismus Care Through a Multicenter Study: Japanese Strabismus Outcomes Assessment and Research (J-SOAR) Group Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Success rate of ocular deviation correction and residual deviation angle
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Strabismus Cohort
Patients diagnosed with strabismus who underwent clinical evaluation or management (including observation for natural history, conservative treatment, or surgery) at participating institutions.
Intervention: Strabismus Surgery (Procedure)
Strabismus Cohort
Patients diagnosed with strabismus who underwent clinical evaluation or management (including observation for natural history, conservative treatment, or surgery) at participating institutions.
Intervention: Conservative Treatment or Observation (Other)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Manabu Miyata
Junior Associate Professor
Kyoto University, Graduate School of Medicine