Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-28 @ 10:17 AM
Study NCT ID:
NCT06850168
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
Sponsor:
Essilor International
Organization:
Study Overview
Official Title:
Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
Status:
RECRUITING
Status Verified Date:
2025-08
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:
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?
Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.
Participants will:
* Wear the study spectacles
* Visit Essilor R\&D Centre for follow-up sessions
Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?
Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.
Participants will:
* Wear the study spectacles
* Visit Essilor R\&D Centre for follow-up sessions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: