Kyoto University Graduate School of Medicine
Kyoto, 606-8507, Japan
Location contact
Manabu Miyata, MD, PhD
CONTACT
Manabu Miyata, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07763457
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.
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Observational
Kyoto, 606-8507, Japan
Manabu Miyata, MD, PhD
CONTACT
Manabu Miyata, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical correction of ocular deviation.
Non-surgical management, including clinical observation for natural history, prism therapy, or orthoptic treatment.
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.
Time frame: Through study completion, up to 10 years
Evaluate binocularity using standardized clinical tests.
Time frame: Through study completion, up to 10 years
Compare the predictive performance of the developed machine learning models against actual surgical outcomes.
Contact information is provided by the study sponsor or research team.
Kyoto University, Graduate School of Medicine
Other
Establishing Real-World Evidence in Japanese Strabismus Care Through a Multicenter Study: Japanese Strabismus Outcomes Assessment and Research (J-SOAR) Group Study
Acronym: J-SOAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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