NCT06598423 Wavelength Intervention for Nearsighted Kids
| NCT ID | NCT06598423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-04-10 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Safal Khanal, OD, PhD
PRINCIPAL INVESTIGATOR
Unversity of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06598423 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 12 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06598423 currently recruiting?
Yes, NCT06598423 is actively recruiting participants. Contact the research team at sgurral2@uab.edu for enrollment information.
Where is the NCT06598423 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06598423 clinical trial?
NCT06598423 is sponsored by University of Alabama at Birmingham. The principal investigator is Safal Khanal, OD, PhD at Unversity of Alabama at Birmingham. The trial plans to enroll 80 participants.