The goal of this clinical trial is to learn if spectacle films 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 in myopic children. The first stage of the trial compares spectacle films using A.R.R.E.S.T.® technology to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing spectacle films using A.R.R.E.S.T.® technology. The main questions to answer are: Do spectacle films using A.R.R.E.S.T.® technology slow down the rate of axial length growth? Do spectacle films using A.R.R.E.S.T.® technology slow down the rate of increase in myopic refractive error? Researchers will compare spectacle films using A.R.R.E.S.T.® technology to a single vision spectacle lens for 12 months followed by assessing spectacle films using A.R.R.E.S.T.® technology for slowing down myopia progression for another 12 months. Participants will initially be randomly allocated to wear either spectacle films using A.R.R.E.S.T.® technology or single vision spectacle lenses and visit the clinic on seven occasions over a 12 month period. After completing the first 12 months, all participants will wear spectacle films using A.R.R.E.S.T.® technology and visit the clinic on five occasions over the second 12 month period.
The aims of this clinical trial are: 1. To compare the rate of myopia progression as measured by change from the Stage 1 Dispensing visit (up to 40 days from Baseline), in axial length and the change from Baseline in the cycloplegic spherical equivalent autorefraction between spectacle films using A.R.R.E.S.T.® technology (test) and single vision spectacle lenses (control). Myopic children (6-14 years of age) will be randomly allocated to wear either test control. 2. To assess the rate of myopia progression as measured by change from the Stage 2 Dispensing visit (up to 40 days from the Stage 1: 12-months visit), in axial length and the change from the Stage 1: 12-months visit in the cycloplegic spherical equivalent autorefraction while wearing spectacle films using A.R.R.E.S.T.® technology. The myopic children from Stage 1 will enter Stage 2. The overall trial duration, including follow-up period, is expected to be approximately 30 months. Each participant's duration is expected to be approximately 24 months. The visits are: Stage 1: Baseline, Dispensing, 1-month, 3-months, 6 months,9-months, and 12-months. Stage 2: Dispensing, 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
123
Standard single vision spectacle lens
A.R.R.E.S.T. spectacle film
Ha Noi Eye Hospital 2
Hà Nội, Vietnam
Axial Length
Difference in change from Stage 1 dispensing in axial length between test and control. The change in axial length from the Stage 2 dispensing.
Time frame: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 3-, 6-, 9-, and 12- months after Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12-months:), then 3-, 6-, 9-, and 12- months after Dispensing Visit.
Cycloplegic spherical equivalent autorefraction
Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between test and control. The change in cycloplegic spherical equivalent autorefraction from the Stage 1: 12-months visit.
Time frame: Stage 1: Baseline, then 6- and 12- months after Dispensing Visit (up to 40 days from Baseline). Stage 2: Stage 1: 12-months visit, then 6- and 12-months after Stage 2 Dispensing Visit (up to 40 days from Stage 1: 12 months visit).
Visual performance as measured by high contrast visual acuity at 6 m
Difference in high contrast visual acuity at 6 m between test and control. High contrast visual acuity at 6 m while wearing spectacle films using A.R.R.E.S.T.® technology.
Time frame: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 3-, 6-, 9-, and 12-months after Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12-months visit), then 3-, 6-, 9-, and 12-months after Dispensing Visit.
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. Subjective visual performance while wearing spectacle films using A.R.R.E.S.T.® technology.
Time frame: Stage 1: 1-, 3-, 6-, 9-, and 12-months after Dispensing Visit (up to 40 days from Baseline). Stage 2: 3-, 6-, 9-, and 12-months after Dispensing Visit (up to 40 days from Stage 2: 12-months Visit).
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