MyopiaWINKNCT06598423
Wavelength Intervention for Nearsighted Kids
A study testing Specialized soft contact lens 1 and Specialized soft contact lens 2 in people with Myopia, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Specialized soft contact lens 1 and Specialized soft contact lens 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2025to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham School of Optometry
Birmingham, Alabama, 35233
Safal Khanal, OD, PhD, 205.934.4558, skhanal@uab.edu
Sindhu Gurrala, MPH, 205.975.3881, sgurral2@uab.edu
About this study
Official title: 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.
Read more
Participants will
- 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.
- Visit the clinic at 2 weeks, 1 month, 3 months, 6 months, and 12 months for checkups and tests
- Keep a diary of the lens-wearing times.
Read the 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.
- Conditions
- Myopia
- Being tested
- Specialized soft contact lens 1, Specialized soft contact lens 2
- Keywords
- Childhood Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized soft contact lens 1Device
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 2Device
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Specialized soft contact lens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12 months
Secondary outcomes (3)
Change in choroidal thickness
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.
Measured: Baseline and 12 months
Change in visual acuity
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.
Measured: Baseline and 12 months
Change in accommodative response
A Grand Seiko autorefractor WAM 5500 will be used to measure accommodative response while fixating at 20/100 letters at 40 and 25 cm.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Apr 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Safal Khanal, University of Alabama at Birmingham
- Investigators
- Safal Khanal, OD, PhD, Principal investigator, Unversity of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598423
- Sponsor's protocol ID
- 300013348
- Other IDs
- R21EY036536
- Acronym
- WINK
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34382245Gawne 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.
PubMed 33984119Gawne 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.
PubMed 40494187