Clinical trial NCT06598423: Wavelength Intervention for Nearsighted Kids
Official title: Pilot Test of a Novel Wavelength-Based Method to Control Childhood Myopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Childhood Myopia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* Spherical equivalent refractive error between -0.75 and -4.00 D
* Less than 1.00 D of astigmatism or anisometropia
* History of soft contact lens wear for at least one month
* 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.

Primary outcomes:
measure: Change in cycloplegic spherical equivalent refractive error
timeFrame: Baseline and 12 months
measure: Change in axial length
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in choroidal thickness
timeFrame: Baseline and 12 months
measure: Change in visual acuity
timeFrame: Baseline and 12 months
measure: Change in accommodative response
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Optometry
state: Alabama
Study officials:
affiliation: Unversity of Alabama at Birmingham
name: Safal Khanal, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.