Myopia
Conditions
Keywords
Childhood Myopia
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.
Interventions
DEVICESpecialized 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.
DEVICESpecialized 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.
Sponsors
National Eye Institute (NEI)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cycloplegic spherical equivalent refractive error | 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. |
| Change in axial length | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in choroidal thickness | 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. |
| Change in visual acuity | 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. |
| Change in accommodative response | 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. |
Countries
United States
Contacts
Primary ContactSindhu Gurrala, MPH
Outcome results
None listed