Establishing Real-World Evidence in Japanese Strabismus Care Through a Multicenter Study: Japanese Strabismus Outcomes Assessment and Research (J-SOAR) Group Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Success rate of ocular deviation correction and residual deviation angle
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who formally opted out of data utilization for this study.
研究组 & 干预措施
Strabismus Cohort
Patients diagnosed with strabismus who underwent clinical evaluation or management (including observation for natural history, conservative treatment, or surgery) at participating institutions.
干预措施: 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.
干预措施: Conservative Treatment or Observation (Other)
结局指标
主要结局
Success rate of ocular deviation correction and residual deviation angle
时间窗: 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.
次要结局
- 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)
研究者
Manabu Miyata
Junior Associate Professor
Kyoto University, Graduate School of Medicine
