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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06148519

Enrollment

250

Registered

2023-11-28

Start date

2023-08-23

Completion date

2024-04-30

Last updated

2025-02-20

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

Conditions

2WIN-S Portable Refractor

Keywords

Refraction, vision screening, preschool aged children

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.

Interventions

DIAGNOSTIC_TEST2WIN-S portable refractor

All participants will be tested by 2WIN-S portable refractor without eye dilatation. If the 2WIN-S reports non-referral, participant will be tested visual acuity by optometrist. If the 2WIN-S reports referral, participant will be tested cycloplegic refraction by pediatric ophthalmologist, then tested by 2WIN-S again. The participant whose result is abnormal will be referred to the hospital for further management.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 6 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Significant refractive errors defined by AAPOS	At 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

Measure	Time frame	Description
Diagnostic accuracy for Amblyopia	At baseline.	Diagnostic accuracy for Amblyopia, measuring by 2WIN-S device and pediatric ophthalmologist.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026