Wavelength Intervention for Nearsighted Kids

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change in cycloplegic spherical equivalent refractive error [Срок оценки: Baseline and 12 months]
• Change in axial length [Срок оценки: Baseline and 12 months]

Вторичные конечные точки (3)

• Change in choroidal thickness [Срок оценки: Baseline and 12 months]
• Change in visual acuity [Срок оценки: Baseline and 12 months]
• Change in accommodative response [Срок оценки: Baseline and 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Alabama at Birmingham School of Optometry — Birmingham

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT06598423 · 300013348 · R21EY036536

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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