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Wavelength Intervention for Nearsighted Kids

NCT06598423 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-08

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

DEVICE

Specialized 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.

DEVICE

Specialized 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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Safal Khanal, OD, PhD · Unversity of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2027-07-01
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598423 on ClinicalTrials.gov