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Japanese Strabismus Outcomes Assessment and Research Group Study

ConditionStrabismus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKyoto University, Graduate School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who formally opted out of data utilization for this study.

Trial population

Patients diagnosed with strabismus who visited participating academic and high-volume eye centers in Japan for clinical evaluation, conservative treatment, or surgery.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Strabismus Surgery

    Procedure/Surgery

    Surgical correction of ocular deviation.

  • Conservative Treatment or Observation

    Other intervention

    Non-surgical management, including clinical observation for natural history, prism therapy, or orthoptic treatment.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Strabismus Cohort2 interventions

Trial outcomes

Primary outcomes

1

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.

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.

Secondary outcomes

1

Recovery of binocular visual function

Evaluate binocularity using standardized clinical tests.

Time frame
Through study completion, up to 10 years
2

Predictive accuracy of the machine learning nomogram

Compare the predictive performance of the developed machine learning models against actual surgical outcomes.

Time frame
Through study completion, up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyoto University, Graduate School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: