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TerminatedNCT06148519Updated Feb 20, 2025

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

An interventional study of 2WIN-S portable refractor in 2WIN-S Portable Refractor, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Terminated at 1 site in Thailand. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Not applicable, Interventional, and Screening

Why this study was terminated
Because the research team plans to change the protocol, we do not plan to conduct cycloplegic refraction, which requires dilation. Instead, we will use only 2-WINS for eye and vision screening. Additionally, we will change the study site
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 2WIN-S Portable Refractor

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Keywords

  • Refraction
  • vision screening
  • preschool aged children
03

In context

Amblyopia

183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.

This study's enrollment of 250 is above the median of 60 across 133 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 36 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • other eye conditions causing visual and 2WIN-S portable refractor working disturbance such as media opacity, history of ocular surgery, strabismus, etc.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Using 2WIN-S portable refractor for amblyopia screening

    Diagnostic Test: 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.

06

What researchers measure

Primary outcomes

  1. Significant refractive errors defined by AAPOS

    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.

    Time frame: At baseline.

Secondary outcomes

  1. Diagnostic accuracy for Amblyopia

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

    Time frame: At baseline.

07

Study locations

1 site
  • Rajavithi Hospital
    Bangkok, 10400, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06148519
Lead sponsor
Department of Medical Services Ministry of Public Health of Thailand
Responsible party
Sponsor
First posted
Nov 28, 2023
Start date
Aug 23, 2023
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
Feb 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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