Wavelength Intervention for Nearsighted Kids (WINK)

October 7, 2025 updated by: Safal Khanal, University of Alabama at Birmingham

Pilot Test of a Novel Wavelength-Based Method to Control Childhood Myopia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Myopia (nearsightedness) is a major public health concern. The prevalence of myopia continues to rise globally, including in the United States. Myopia develops when the eye grows excessively long for its optics, producing out-of-focus images of distant objects on the retina. Blurry distant vision in myopia can be easily corrected by traditional optical and surgical means. However, these methods do nothing to slow myopia-associated excessive axial elongation of the eye which is a major risk factor for several sight-threatening ocular pathologies, such as myopia maculopathy and retinal detachment later in life. Interventions to slow axial elongation and therefore myopia will have a significant public health benefit.

This randomized controlled clinical trial will test the efficacy of wearing specialized soft contact lenses in slowing the progression of myopia in children. In this pilot trial, children with myopia will wear daily use, daily disposable, single-vision soft contact lenses in both eyes for one year. One group will wear a single type of soft contact lens full-time daily whereas the other group will wear two types of soft contact lenses daily at alternate times. The two lenses are identical in material, comfort, and lens geometry and different only in their spectral profile.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham School of Optometry
        • Principal Investigator:
          • Safal Khanal, OD, PhD
        • Sub-Investigator:
          • Timothy J Gawne, PhD
        • Sub-Investigator:
          • Katherine K Weise, OD, MBA
        • Sub-Investigator:
          • Thomas T Norton, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cycloplegic spherical equivalent refractive error
Time Frame: Baseline and 12 months
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
Time Frame: Baseline and 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in choroidal thickness
Time Frame: Baseline and 12 months
Subjects will have cross-sectional chorio-retinal images taken in each eye using a high resolution scan centered on the fovea in the enhanced depth imaging mode. After the scanning is complete, images will be exported in original resolution for offline processing in MATLAB using custom software that will segment layers and automatically measure choroidal thickness at various regions (subfoveal, central, parafoveal, peripheral) as the distance between the retinal pigment epithelium/choroid interface and the choroidoscleral interface.
Baseline and 12 months
Change in visual acuity
Time Frame: Baseline and 12 months
High-contrast distance visual acuity (VA) will be measured at 4 m with ETDRS Charts and near VA will be measured at 40 cm with Near Point Flip Charts. Low-contrast VA will be measured using 10% contrast Bailey Lovey charts. Monocular VA will be recorded in logMAR to the nearest letter on charts standardized to a luminance of 85 cd/m2.
Baseline and 12 months
Change in accommodative response
Time Frame: Baseline and 12 months
A Grand Seiko autorefractor WAM 5500 will be used to measure accommodative response while fixating at 20/100 letters at 40 and 25 cm.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Safal Khanal, OD, PhD, Unversity of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 7, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300013348
  • R21EY036536 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in myopia. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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