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

• Sponsor: Rajavithi Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06148519
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.2
• Patients Per Site Per Month: 30.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
2WIN-S Portable Refractor	Diagnostic Test: 2WIN-S portable refractor	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor With Vision Screening by Cycloplegic Refraction in Bangkok
• Actual Study Start Date: Aug 23, 2023
• Anticipated Primary Completion Date: Apr 30, 2024
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

Arm

Intervention/Treatment

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

Diagnostic Test: 2WIN-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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Diagnostic accuracy for Amblyopia [At baseline.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rajavithi Hospital	Bangkok		Thailand	10400

Sponsors and Collaborators

• Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rajavithi Hospital
• ClinicalTrials.gov Identifier: NCT06148519
• Other Study ID Numbers: 162/2566
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rajavithi Hospital: Refraction; vision screening; preschool aged children
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Nov 28, 2023