NCT06148519

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

February 20, 2025

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

November 20, 2023

Last Update Submit

February 18, 2025

Conditions

2WIN-S Portable Refractor

Keywords

Refractionvision screeningpreschool aged children

Outcome Measures

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.

    At baseline.

Secondary Outcomes (1)

  • Diagnostic accuracy for Amblyopia

    At baseline.

Study Arms (1)

Using 2WIN-S portable refractor for amblyopia screening

EXPERIMENTAL
Diagnostic Test: 2WIN-S portable refractor

Interventions

2WIN-S portable refractorDIAGNOSTIC_TEST

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.

Using 2WIN-S portable refractor for amblyopia screening

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

August 23, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

February 20, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)