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RECRUITING Not applicable ClinicalTrials.gov

Wavelength Intervention for Nearsighted Kids

Sponsor: University of Alabama at Birmingham • ClinicalTrials.gov ID: NCT06598423

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Specialized soft contact lens 1 (Device)
    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.
  • Specialized soft contact lens 2 (Device)
    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.

Eligibility criteria

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 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.

Conditions

Myopia

Locations

  • University of Alabama at Birmingham School of Optometry — Birmingham, Alabama, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record