Refractive Error - Myopia AxialNCT04249505
Refractive Accuracy of "2WIN" and Portable Autorefractors
An observational study of Refractive Error - Myopia Axial and Astigmatism, run by Alaska Blind Child Discovery at 1 site in United States.
Trial summary
Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction. Read more about this study
- Who is it for?
- Ages 6 months to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Error - Myopia Axial, Astigmatism, Accomodation
- What is being tested?
- "2WIN" Photoscreener, "Plusoptix A12" and "Retinomax"
- Type of treatment
- Medical device
- How many people
- 708 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 1 Apr 2021
- Phase
- Observational
- 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 6 months to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: children and adults attending pediatric ophthalmology and adult strabismus clinic
Who may be able to join
- Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included
Who cannot join
- Intraocular lens in place
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Children's EYE & Strabismus
Anchorage, Alaska, 99508
About this study
Official title: The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor
Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction.
Read the detailed description
A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience.
As a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools.
The ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg, Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm.
This algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.
- Conditions
- Refractive Error - Myopia Axial, Astigmatism, Accomodation, Visual Impairment, Hyperopia of Both Eyes
- Being tested
- "2WIN" Photoscreener, "Plusoptix A12", "Retinomax"
- Keywords
- photoscreening, photo refraction, auto refraction, spectacle dispensing
- Medical subject headings
- Astigmatism, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"2WIN" PhotoscreenerDevice
non-cycloplegia refraction by Adaptica "2WIN"
"Plusoptix A12"Device
non-cycloplegic refraction by "Plusoptix A12" photoscreener
"Retinomax"Device
non-cycloplegic refraction by "Retinomax K+" auto refractor
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive Accuracy
spherical equivalent
Measured: 1 day
Refractive Accuracy
Vector transform J0 and J45 astigmatism
Measured: 1 day
Refractive Accuracy
Spectacle comparison score (Percent similarity combined sphere-cylinder)
Measured: 1 day
Secondary outcomes (1)
Impact of age
Spectacle similarity score striated by age relative to patient's ability to accommodate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start9 Jan 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive Error - Myopia AxialStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bob Arnold, MD, Principal investigator, Coordinator Alaska Blind Child Discovery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249505
- Sponsor's protocol ID
- ABCD RefAcc
- Status last verified
- Jul 2020
- First submitted
- 29 Jan 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identified database shared on www.ABCD-Vision.org Website.
Publications
Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.
PubMed 31077668
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor
- ClinicalTrials.gov ID
- NCT04249505
- Acronym / sponsor ID
- ABCD RefAcc
- Conditions
- Refractive Error - Myopia Axial, Astigmatism, Accomodation, Visual Impairment, Hyperopia of Both Eyes
- Keywords
- photoscreening, photo refraction, auto refraction, spectacle dispensing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 31 Jan 2020 (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.
Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction.
Detailed description
A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience.
As a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools.
The ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg, Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm.
This algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 months to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children and adults attending pediatric ophthalmology and adult strabismus clinic
Key inclusion criteria (1 listed)
- Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included
Key exclusion criteria (1 listed)
- Intraocular lens in place
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" Photoscreenernon-cycloplegia refraction by Adaptica "2WIN" | Device | – |
| "Plusoptix A12"non-cycloplegic refraction by "Plusoptix A12" photoscreener | Device | – |
| "Retinomax"non-cycloplegic refraction by "Retinomax K+" auto refractor | Device | – |
Primary outcome
Refractive Accuracy
Time frame: 1 day
spherical equivalent
Refractive Accuracy
Time frame: 1 day
Vector transform J0 and J45 astigmatism
Refractive Accuracy
Time frame: 1 day
Spectacle comparison score (Percent similarity combined sphere-cylinder)
1 secondary outcome
Impact of age
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Background: PubMed 31077668Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.
- Individual participant dataSharing planned: Yes. de-identified database shared on www.ABCD-Vision.org Website.
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.
Bob Arnold, MD principal investigator
Coordinator Alaska Blind Child Discovery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Error - Myopia Axial and Astigmatism, run by Alaska Blind Child Discovery at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 23 Jul 2021. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Refractive Accuracy (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249505, which also lists 1 linked publication.
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 23 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.