Wavelength Intervention for Nearsighted Kids

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06598423
Status
Recruiting
Apply to this trial

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
7 Years - 12 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Apr 10, 2025
Status verified
Oct 2025
Primary completion
Jul 1, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Children who are randomized to this group will wear one type of daily use, daily disposable, single-vision soft contact lens for at least four hours starting in the afternoon (after school) and another type of daily use, daily disposable, single-vision soft contact lens for the remainder of the time daily for one year.
  • Sham Comparator: Control group
    Children who are randomized to this group will wear daily use, daily disposable, single-vision soft contact lenses full time for one year. Contact lenses will be worn for a minimum of 10 hours per day.

Primary Outcome Measure

Change in cycloplegic spherical equivalent refractive error [ Time Frame: Baseline and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham School of OptometryBirminghamAlabama35233
Safal Khanal, OD, PhD
[email protected]
205.934.4558
Sindhu Gurrala, MPH
[email protected]
205.975.3881
Safal Khanal, OD, PhD (PRINCIPAL_INVESTIGATOR)
Timothy J Gawne, PhD (SUB_INVESTIGATOR)
Katherine K Weise, OD, MBA (SUB_INVESTIGATOR)
Thomas T Norton, PhD (SUB_INVESTIGATOR)

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By research site
University of Alabama at Birmingham School of Optometry· Birmingham, AL

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