Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598423
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Wavelength Intervention for Nearsighted Kids
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Test of a Novel Wavelength-Based Method to Control Childhood Myopia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
WINK
Brief Summary:
The goal of this clinical trial is to learn if daily brief periods of specialized soft contact lens wear work to slow the progression of nearsightedness in children Additionally the study will learn about the compliance and safety of specialized soft contact lens wear in children The main questions it aims to answer are
Does wearing specialized soft contact lenses daily slow myopia progression and axial elongation What visualocular problems do participants have when wearing specialized soft contact lenses Researchers will compare two soft contact lenses to see if specialized soft contact lens wear works to treat childhood myopia progression
Participants will
1 Wear either a single type of soft contact lens or two types of soft contact lenses at alternate times daily full time in both eyes for one year
2 Visit the clinic at 2 weeks 1 month 3 months 6 months and 12 months for checkups and tests
3 Keep a diary of the lens-wearing times
Does wearing specialized soft contact lenses daily slow myopia progression and axial elongation What visualocular problems do participants have when wearing specialized soft contact lenses Researchers will compare two soft contact lenses to see if specialized soft contact lens wear works to treat childhood myopia progression
Participants will
1 Wear either a single type of soft contact lens or two types of soft contact lenses at alternate times daily full time in both eyes for one year
2 Visit the clinic at 2 weeks 1 month 3 months 6 months and 12 months for checkups and tests
3 Keep a diary of the lens-wearing times
Detailed Description:
Myopia nearsightedness is a major public health concern The prevalence of myopia continues to rise globally including in the United States Myopia develops when the eye grows excessively long for its optics producing out-of-focus images of distant objects on the retina Blurry distant vision in myopia can be easily corrected by traditional optical and surgical means However these methods do nothing to slow myopia-associated excessive axial elongation of the eye which is a major risk factor for several sight-threatening ocular pathologies such as myopia maculopathy and retinal detachment later in life Interventions to slow axial elongation and therefore myopia will have a significant public health benefit
This randomized controlled clinical trial will test the efficacy of wearing specialized soft contact lenses in slowing the progression of myopia in children In this pilot trial children with myopia will wear daily use daily disposable single-vision soft contact lenses in both eyes for one year One group will wear a single type of soft contact lens full-time daily whereas the other group will wear two types of soft contact lenses daily at alternate times The two lenses are identical in material comfort and lens geometry and different only in their spectral profile
This randomized controlled clinical trial will test the efficacy of wearing specialized soft contact lenses in slowing the progression of myopia in children In this pilot trial children with myopia will wear daily use daily disposable single-vision soft contact lenses in both eyes for one year One group will wear a single type of soft contact lens full-time daily whereas the other group will wear two types of soft contact lenses daily at alternate times The two lenses are identical in material comfort and lens geometry and different only in their spectral profile
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