Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346626
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-03-26
Brief Title:
To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children
Sponsor:
He Eye Hospital
Organization:
He Eye Hospital
Study Overview
Official Title:
To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Myopia also known as short-sightedness or near-sightedness is a prevalent condition that typically emerges during childhood and early adulthood It occurs when the eye elongates excessively causing images of distant objects to focus in front of the retina leading to blurred distance vision The number of people with myopia is increasing every year reaching half of the worlds population by 2050 The global potential productivity loss due to uncorrected refractive errors was 244 billion in 2015 Due to the strong association between high myopia and pathological changes in the choroid retina and sclera leading to irreversible vision loss and the fact that correcting the refractive error does not halt the progression of pathology the prevention of myopia especially high myopia has emerged as a crucial international public health concern In ocular examinations of children under noncycloplegic conditions the influence of accommodation cannot be disregarded
Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations Moreover due to childrens decreased cooperation and unreliable responses subjective refraction tests are less valued and objective tests under cycloplegia are preferred The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes Along with measuring phoriastropias in prismatic diopters and objective refraction in the range of -15D to 15D 2WIN-S also captures additional features
This study employed the cycloplegic condition to measurements using 2WIN-S ARK-1 and subjective testing we wanted to test the reliability and accuracy of 2WIN-S
Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations Moreover due to childrens decreased cooperation and unreliable responses subjective refraction tests are less valued and objective tests under cycloplegia are preferred The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes Along with measuring phoriastropias in prismatic diopters and objective refraction in the range of -15D to 15D 2WIN-S also captures additional features
This study employed the cycloplegic condition to measurements using 2WIN-S ARK-1 and subjective testing we wanted to test the reliability and accuracy of 2WIN-S
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None