Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT06450132
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Eye Shape With Myopia Management Interventions
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses
Status:
RECRUITING
Status Verified Date:
2024-10
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 clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:
* do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
* are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?
Participants will:
* have multiple different types of photos taken
* have their prescription for glasses/contacts checked
* have their eye health checked, including the use of dilating eye drops
* be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
* will complete five study visits over the course of 12 months
Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.
* do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
* are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?
Participants will:
* have multiple different types of photos taken
* have their prescription for glasses/contacts checked
* have their eye health checked, including the use of dilating eye drops
* be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
* will complete five study visits over the course of 12 months
Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: