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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: t
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham School of Optometry
RECRUITING
Birmingham
Contact Information
Primary
Sindhu Gurrala, MPH
sgurral2@uab.edu
205.975.3881
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 80
Treatments
Experimental: Group A
Children who are randomized to this group will wear one type of daily use, daily disposable, single-vision soft contact lens for at least four hours starting in the afternoon (after school) and another type of daily use, daily disposable, single-vision soft contact lens for the remainder of the time daily for one year.
Sham_comparator: Control group
Children who are randomized to this group will wear daily use, daily disposable, single-vision soft contact lenses full time for one year. Contact lenses will be worn for a minimum of 10 hours per day.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: National Eye Institute (NEI)

This content was sourced from clinicaltrials.gov