Wearing special contact lenses to slow nearsightedness in children
Pilot Test of a Novel Wavelength-Based Method to Control Childhood Myopia
This study is testing if special contact lenses can help slow down nearsightedness in children over the course of a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06598423 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if wearing specialized soft contact lenses can slow the progression of myopia in children. Participants will wear either one type of lens or alternate between two types of lenses daily for a year. The study will involve regular clinic visits for checkups and tests, as well as diary entries to track lens-wearing times. The research focuses on the effectiveness, compliance, and safety of these lenses in managing childhood myopia.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 12 with myopia and a specific range of refractive error who have experience wearing soft contact lenses.
Not a fit: Patients who have received myopia control treatments recently or have certain ocular or systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the progression of nearsightedness in children, potentially preventing serious ocular complications later in life.
How similar studies have performed: Other studies have shown promising results with similar approaches to managing myopia in children, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham School of Optometry — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Safal Khanal, OD, PhD — Unversity of Alabama at Birmingham
- Study coordinator: Sindhu Gurrala, MPH
- Email: sgurral2@uab.edu
- Phone: 205.975.3881
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.