Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05894382
Status:
RECRUITING
Last Update Posted:
2023-06-08
First Post:
2023-05-30
Brief Title:
Double Helix Design Defocus Lens Spectacle RACE for Myopia Control
Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Organization:
Shanghai Eye Disease Prevention and Treatment Center
Study Overview
Official Title:
A Randomized Controlled Study on the Effectiveness Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents and Control of Myopia
Status:
RECRUITING
Status Verified Date:
2023-05
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:
This study uses 1585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images In addition the helical arrangement and reduced slit area can generate defocusing signals inhibiting the development of myopia Therefore based on previous research this study plans to evaluate the safety and effectiveness of 1585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial
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