Astigmatism Clinical Trial
Official title:
The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor
NCT number | NCT04249505 |
Other study ID # | ABCD RefAcc |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 9, 2020 |
Est. completion date | April 1, 2021 |
Verified date | July 2020 |
Source | Alaska Blind Child Discovery |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 708 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 95 Years |
Eligibility | Inclusion Criteria: - Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included Exclusion Criteria: - Intraocular lens in place |
Country | Name | City | State |
---|---|---|---|
United States | Alaska Children's EYE & Strabismus | Anchorage | Alaska |
Lead Sponsor | Collaborator |
---|---|
Alaska Blind Child Discovery |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Refractive Accuracy | spherical equivalent | 1 day | |
Primary | Refractive Accuracy | Vector transform J0 and J45 astigmatism | 1 day | |
Primary | Refractive Accuracy | Spectacle comparison score (Percent similarity combined sphere-cylinder) | 1 day | |
Secondary | Impact of age | Spectacle similarity score striated by age relative to patient's ability to accommodate | 1 day |
Status | Clinical Trial | Phase | |
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