Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577948
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
The PAUSE Spectacle Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Spectacle Lenses Utilising PAUSE Technology for Slowing Down Myopia Progression in Vietnamese Children A Prospective Masked Controlled Randomised Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements PAUSE technology works to slow down the rate of myopia progression compared to single vision spectacle lenses in myopic children The main questions it aims to answer are
Do spectacle lenses using PAUSE technology slow down the rate of axial length growth Do spectacle lenses using PAUSE technology slow down the rate of increase in myopic refractive error
Researchers will compare spectacle lenses using PAUSE technology to a single vision spectacle lens
Participants will
Be randomly allocated to wear either spectacle lenses using PAUSE technology or single vision spectacle lenses
Visit the clinic on five occasions over a 12 month period
Do spectacle lenses using PAUSE technology slow down the rate of axial length growth Do spectacle lenses using PAUSE technology slow down the rate of increase in myopic refractive error
Researchers will compare spectacle lenses using PAUSE technology to a single vision spectacle lens
Participants will
Be randomly allocated to wear either spectacle lenses using PAUSE technology or single vision spectacle lenses
Visit the clinic on five occasions over a 12 month period
Detailed Description:
The aim of this clinical trial is to compare the rate of myopia progression as measured by change from the Dispensing visit up to 26 days from Baseline in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between two spectacle lens designs using PAUSE technology tests and single vision spectacle lenses control Myopic children 6-14 years of age will be randomly allocated to wear either test 1 test 2 or control
The overall trial duration including follow-up period is expected to be approximately 18 months Each participants duration is expected to be approximately 12 months
The visits are Baseline Dispensing 1 month 6 months and 12 months
All procedures performed at these visits are standard non invasive clinical tests
The overall trial duration including follow-up period is expected to be approximately 18 months Each participants duration is expected to be approximately 12 months
The visits are Baseline Dispensing 1 month 6 months and 12 months
All procedures performed at these visits are standard non invasive clinical tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None