2WIN-S Portable RefractorNCT06148519
Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok
A study testing 2WIN-S portable refractor in people with 2WIN-S Portable Refractor, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- 2WIN-S Portable Refractor
- What is being tested?
- 2WIN-S portable refractor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteThailand
- Study dates
- 23 Aug 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- other eye conditions causing visual and 2WIN-S portable refractor working disturbance such as media opacity, history of ocular surgery, strabismus, etc.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- 2WIN-S Portable Refractor
- Being tested
- 2WIN-S portable refractor
- Keywords
- Refraction, vision screening, preschool aged children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Using 2WIN-S portable refractor for amblyopia screening | Experimental | Not described Receives: Diagnostic Test: 2WIN-S portable refractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline.
Secondary outcomes (1)
Diagnostic accuracy for Amblyopia
Diagnostic accuracy for Amblyopia, measuring by 2WIN-S device and pediatric ophthalmologist.
Measured: At baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start23 Aug 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2WIN-S Portable RefractorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148519
- Sponsor's protocol ID
- 162/2566
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok
- ClinicalTrials.gov ID
- NCT06148519
- Acronym / sponsor ID
- 162/2566
- Conditions
- 2WIN-S Portable Refractor
- Keywords
- Refraction, vision screening, preschool aged children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Using 2WIN-S portable refractor for amblyopia screening | Experimental | Diagnostic Test: 2WIN-S portable refractor |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- other eye conditions causing visual and 2WIN-S portable refractor working disturbance such as media opacity, history of ocular surgery, strabismus, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2WIN-S portable refractorAll 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. | Diagnostic test | Using 2WIN-S portable refractor for amblyopia screening |
Primary outcome
Significant refractive errors defined by AAPOS
Time frame: 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.
1 secondary outcome
Diagnostic accuracy for Amblyopia
Time frame: At baseline.
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2WIN-S portable refractor in people with 2WIN-S Portable Refractor, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant refractive errors defined by AAPOS (time frame: At baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.