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Validation of the Diagnostic Methodology of BOKE EyeScan for the Quantitative Measurement of the Angle of Strabismus

Validation of the Diagnostic Methodology of BOKE EyeScan for the Quantitative Measurement of the Angle of Strabismus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126694
Enrollment
Unknown
Registered
2026-06-14
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strabismus

Interventions

Gold Standard:Prism and Alternate Cover Test
Index test:BOKE Eyescan

Sponsors

Eye Hospital, Wenzhou Medical University at Hangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 5 to 18 years (inclusive), regardless of sex; 2. Diagnosed with simple strabismus, or healthy controls matched for age and sex with strabismus patients; 3. Able to cooperate with the examiner to complete both the Ocular Alignment Capture System (OACS) assessment and the gold-standard Prism and Alternate Cover Test (PACT); 4. Capable of fixating on a visual target with at least one eye; 5. Voluntary participation with written informed consent provided by the participant and/or their legal guardian prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Best-corrected visual acuity (BCVA) = 70 prism diopters (PD) as measured by the Prism and Alternate Cover Test (PACT); 4. Physical or developmental disabilities, or psychiatric conditions that preclude the participant from cooperating with and completing the required examinations.

Design outcomes

Primary

MeasureTime frame
Intraclass Correlation Coefficient, ICC;Sensitivity;Specificity;Accuracy;Receiver Operating Characteristic(ROC), Area Under the Curve(AUC);

Countries

China

Contacts

Public ContactHou Lijie

Eye Hospital, Wenzhou Medical University at Hangzhou

hord@163.com+86 135 0651 4838

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026