Pilot Test of a Novel Wavelength-Based Method to Control Childhood Myopia
University of Alabama at Birmingham
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 visual/ocular 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.
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 detachmen…
Eligibility
- Age range
- 7–12 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Criteria: * 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…
Interventions
- DeviceSpecialized soft contact lens 1
These are daily-wear, daily-replacement lenses. They are identical to specialized soft contact lens 2 in material, comfort, and lens geometry. They differ only in their spectral profile.
- DeviceSpecialized soft contact lens 2
These are daily-wear, daily-replacement lenses. They are identical to specialized soft contact lens 1 in material, comfort, and lens geometry. They differ only in their spectral profile.
Location
- University of Alabama at Birmingham School of OptometryBirmingham, Alabama