Status:
RECRUITING
Wavelength Intervention for Nearsighted Kids
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Myopia
Eligibility:
All Genders
7-12 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- Spherical component of refractive error in primary meridian between -0.75 and -5.00 D
- Less than 1.00 D of astigmatism or anisometropia
- History of soft contact lens wear for at least a week
- Best-corrected visual acuity of 20/25 (+0.10 logMAR) or better in each eye
- Willingness to wear the lenses for a minimum of 10 hours/day, at least six days a week for the duration of the study
Exclusion
- Subjects receiving myopia control treatments within the past six months
- History of premature (less than 3.3 lb) or preterm birth (earlier than 30 weeks)
- Current history of using systemic or ocular medications (including artificial tears) that may affect contact lens wear, tear film health, refractive state, pupillary response or accommodative function
- History of ocular or systemic diseases, including those that may affect refractive development
- Known allergy to fluorescein, benoxinate, proparacaine, or tropicamide
- Contact lens contraindications (e.g., giant papillary keratoconjunctivitis)
- Corneal disorders (e.g., hypoesthesia, keratoconus)
- Strabismus at distance or near with distance glasses or contact lenses
- Subjects exhibiting poor personal hygiene that may affect the compliance of contact lens wear.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06598423
Start Date
April 10 2025
End Date
July 31 2027
Last Update
October 8 2025
Active Locations (1)
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1
University of Alabama at Birmingham School of Optometry
Birmingham, Alabama, United States, 35233