跳至主要内容
临床试验/NCT07763457
NCT07763457尚未招募不适用

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

Kyoto University, Graduate School of Medicine1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

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

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

发起方
Kyoto University, Graduate School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manabu Miyata

Junior Associate Professor

Kyoto University, Graduate School of Medicine

研究点 (1)

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