Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563700
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Novel Lenses for Myopia Progression Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double Masked Randomised Longitudinal Comparative Study to Evaluate the Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children with Myopia
Status:
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:
This is a multi-center prospective randomised longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens control for 12 months At the end of 12 months those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months Myopia progression during the second year with test lenses will be compared to historical or published controls
Detailed Description:
None
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