RECRUITING

Wavelength Intervention for Nearsighted Kids

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-10

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06598423

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Sindhu Gurrala, MPH

CONTACT

205.975.3881

sgurral2@uab.edu

Principal Investigator

Safal Khanal, OD, PhD

PRINCIPAL_INVESTIGATOR

Unversity of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham School of Optometry

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Safal Khanal, OD, PhD, PRINCIPAL_INVESTIGATOR, Unversity of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-10

Study Completion Date2026-10-31

Study Record Updates

Study Start Date2025-04-10

Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

Childhood Myopia

Additional Relevant MeSH Terms

Myopia