Wavelength Intervention for Nearsighted Kids

NCT06598423 | Recruiting DMC FDA Device

• 2 other identifiers: 300013348R21EY036536
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Visit the clinic at 2 weeks, 1 month, 3 months, 6 months, and 12 months for checkups and tests
3. 3.Keep a diary of the lens-wearing times.

Conditions

Myopia

Keywords

Childhood Myopia

Outcome Measures

Primary Outcomes (2)

• Change in cycloplegic spherical equivalent refractive error

  Cycloplegic autorefraction measurements will be recorded using the WAM 5500 autorefractor in both eyes at baseline and follow-up visits. A set of 10 spherical equivalent measures will be obtained in each eye and later averaged to obtain the eye's final refractive error.

  Baseline and 12 months

• Change in axial length

  Ocular component dimensions, including axial length, will be recorded using the Haag-Streit LenStar LS900 based on low-coherence interferometry. A set of five measurements in primary gaze in each eye will be averaged to obtain the final dimension of the ocular components.

  Baseline and 12 months

Secondary Outcomes (3)

• Change in choroidal thickness

  Baseline and 12 months

• Change in visual acuity

  Baseline and 12 months

• Change in accommodative response

  Baseline and 12 months

Study Arms (2)

Group A

EXPERIMENTAL

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.

Device: Specialized soft contact lens 1

Control group

SHAM COMPARATOR

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.

Device: Specialized soft contact lens 2

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.

Group A

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.

Control group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of Alabama at Birmingham School of Optometry

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (3)

• Khanal S, Norton TT, Gawne TJ. Amber light treatment produces hyperopia in tree shrews. Ophthalmic Physiol Opt. 2021 Sep;41(5):1076-1086. doi: 10.1111/opo.12853. Epub 2021 Aug 11.

  PMID: 34382245 BACKGROUND

• Gawne TJ, Grytz R, Norton TT. How chromatic cues can guide human eye growth to achieve good focus. J Vis. 2021 May 3;21(5):11. doi: 10.1167/jov.21.5.11.

  PMID: 33984119 BACKGROUND

• Gawne TJ, She Z, Khanal S. Human trichromacy and refractive development. Vision Res. 2025 Sep;234:108632. doi: 10.1016/j.visres.2025.108632. Epub 2025 Jun 9.

  PMID: 40494187 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Safal Khanal, OD, PhD

  Unversity of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sindhu Gurrala, MPH

CONTACT

205.975.3881; sgurral2@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators plan to conduct a randomized controlled trial of specialized soft contact lenses for the treatment of myopia. Children will be randomized 1:1 to wearing a single type of soft contact lens or two types of soft contact lenses at alternate times daily for one year.

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact skhanal@uab.edu.

Locations

US (1)