Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358755
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-20
Brief Title:
Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren
Detailed Description:
This study is a two-arm randomised controlled trial with a 18-month duration Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren Optical defocus will be delivered by Defocus Incorporated Multiple Segments DIMS spectacle lenses
A total of 112 Hong Kong Chinese children aged 7 to 12 years 56 in each group will be recruited and randomly allocated into two groups One group will receive low dose atropine 001 plus DIMS spectacles ATD Group another one will receive low dose atropine 001 plus single vision spectacles AT Group
They must have no prior or current myopia control treatment have no ocular or systemic diseasesabnormalities that affect visual function refractive development or spectacle lens wear and no previous intraocular or corneal surgery They must not have allergy to atropine
Their cycloplegic refraction and axial length will be monitored every six months for 18 months The changes in refractive errors and axial length between groups will be compared
A total of 112 Hong Kong Chinese children aged 7 to 12 years 56 in each group will be recruited and randomly allocated into two groups One group will receive low dose atropine 001 plus DIMS spectacles ATD Group another one will receive low dose atropine 001 plus single vision spectacles AT Group
They must have no prior or current myopia control treatment have no ocular or systemic diseasesabnormalities that affect visual function refractive development or spectacle lens wear and no previous intraocular or corneal surgery They must not have allergy to atropine
Their cycloplegic refraction and axial length will be monitored every six months for 18 months The changes in refractive errors and axial length between groups will be compared
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P0041308 | OTHER | The Hong Kong Polytechnic University | None |