The goal of this clinical trial is to learn if contact lenses using Active Reconfiguration in Retinal Encoding of Spatio-Temporal (A.R.R.E.S.T.®) signal technology works to slow down the rate of myopia progression compared to single vision contact lenses in myopic children. The main questions it aims to answer are: Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of axial length growth? Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of increase in myopic refractive error? Researchers will compare contact lenses using A.R.R.E.S.T.® technology to a single vision contact lens. Participants will: Be randomly allocated to wear either contact lenses using A.R.R.E.S.T.® technology or single vision contact lenses. Visit the clinic on seven occasions over a 12 month period.
The aim of this clinical trial is to compare the rate of myopia progression as measured by change from dispensing, in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between a contact lens using A.R.R.E.S.T.® technology (test) and a single vision contact lens (control). Myopic children (7-15 years of age) will be randomly allocated to wear either test or control. The overall trial duration, including follow-up period, is expected to be approximately 18 months. Each participant's duration is expected to be approximately 12 months. The visits are Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months. All procedures performed at these visits are standard, non invasive clinical tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Standard single vision contact lens
Contact lens with edge pattern
Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGOptometry Clinic, Faculty of Health Science, Universiti Kebangsaan Malaysia
Kuala Lumpur, Malaysia
RECRUITINGAxial Length
Difference in change from baseline in axial length between each test and control.
Time frame: Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline
Cycloplegic spherical equivalent autorefraction
Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control.
Time frame: Baseline, then 6 months, and 12 months after baseline
Visual performance as measured by high contrast visual acuity at 6 m
Difference in visual acuity between each test and control.
Time frame: Baseline, then 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after baseline
Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale
Difference in subjective visual performance between test and control after a minimum wear of one month.
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after baseline
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