Actively Recruiting

Phase Not Applicable
Age: 7Years - 12Years
All Genders
Healthy Volunteers
NCT06598423

Wavelength Intervention for Nearsighted Kids

Led by University of Alabama at Birmingham · Updated on 2025-10-08

80

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Wavelength Intervention for Nearsighted Kids

Who Can Participate

Age: 7Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Spherical component of refractive error in primary meridian between -0.75 and -5.00 diopters
  • Less than 1.00 diopter of astigmatism or anisometropia
  • History of soft contact lens wear for at least one week
  • Best-corrected visual acuity of 20/25 (or +0.10 logMAR) or better in each eye
  • Willingness to wear the lenses at least 10 hours per day, six days a week for the study duration
Not Eligible

You will not qualify if you...

  • Use of myopia control treatments within the past six months
  • History of premature birth (less than 3.3 pounds) or preterm birth (earlier than 30 weeks)
  • Current use of systemic or eye medications that may affect contact lens wear, tear health, refractive state, pupil response, or focusing
  • History of eye or systemic diseases that may affect eye development
  • Known allergy to fluorescein, benoxinate, proparacaine, or tropicamide
  • Contact lens contraindications such as giant papillary keratoconjunctivitis
  • Corneal disorders such as reduced corneal sensitivity or keratoconus
  • Strabismus at distance or near while wearing glasses or contact lenses
  • Poor personal hygiene that could affect contact lens wear compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham School of Optometry

Birmingham, Alabama, United States, 35233

Actively Recruiting

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Research Team

S

Sindhu Gurrala, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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