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Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok

Not Applicable
Terminated
Conditions
2WIN-S Portable Refractor
Interventions
Diagnostic Test: 2WIN-S portable refractor
Registration Number
NCT06148519
Lead Sponsor
Rajavithi Hospital
Brief Summary

The goal of this diagnostic test is to compare the results of refraction and amblyopia risks between using 2WIN-S portable refractor and cycloplegic refraction in pre-school age.

All participants will be tested by 2WIN-S portable refractor.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
250
Inclusion Criteria
  • corrected visual acuity 0.1 logMAR (Snellen 20/25) or better
  • Age 3-6 years old who studies in the kindergarten school that joins the study
  • Parents sign informed consent form about allowing their child to join the study
Exclusion Criteria
  • other eye conditions causing visual and 2WIN-S portable refractor working disturbance such as media opacity, history of ocular surgery, strabismus, etc.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Using 2WIN-S portable refractor for amblyopia screening2WIN-S portable refractor-
Primary Outcome Measures
NameTimeMethod
Significant refractive errors defined by AAPOSAt baseline.

Measuring spherical equivalent(SE) and cylinder(Cy), and axis to detect specific target levels of ARFs and visually significant refractive errors, as defined by AAPOS.

Secondary Outcome Measures
NameTimeMethod
Diagnostic accuracy for AmblyopiaAt baseline.

Diagnostic accuracy for Amblyopia, measuring by 2WIN-S device and pediatric ophthalmologist.

Trial Locations

Locations (1)

Rajavithi Hospital

🇹🇭

Bangkok, Thailand

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