Wavelength Intervention for Nearsighted Kids (WINK)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Myopia

Treatments: Device: Specialized soft contact lens 1; Device: Specialized soft contact lens 2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06598423

R21EY036536 (U.S. NIH Grant/Contract)

300013348

Details and patient eligibility

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Device: Specialized soft contact lens 1

Control group

Sham Comparator group

Description:

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.

Treatment:

Device: Specialized soft contact lens 2