Myopia
Conditions
Keywords
spectacle, myopia control, myopia, HAL, Stellest, Essilor
Brief summary
The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.
Interventions
DEVICEinnovative myopia control spectacle lens
using a innovative spectacle lens to control myopia progression
single vision spectacle lens for myopia and astigmatism correction
Sponsors
Essilor International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Equal to or greater than 6 years and not older than 12 years at time of informed consent and assent. * Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.50 D in each eye. * Astigmatism, if present, of not more than 1.50 D. * Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D. * Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen) * Agree to wear spectacles for ≥10 hours/day at least 6 days/week. * Willingness and ability to participate in trial for 3 years and attend scheduled visits.
Exclusion criteria
* History of myopia control intervention (e.g., atropine, orthokeratology, multifocal contact lenses, etc.) * Strabismus by cover test at near or distance wearing correction. * Amblyopia * Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.). * Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. * Current or anticipated use of growth hormones. * Participation in any clinical study within 30 days of the Baseline visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 36 Months | Change in axial length from baseline |
| Cycloplegic spherical equivalent refraction | 36 Months | Change in cycloplegic spherical equivalent refraction from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 24 Months | Change in axial length from baseline |
| Cycloplegic spherical equivalent refraction | 24 Months | Change in cycloplegic spherical equivalent refraction from baseline |
Countries
United States
Outcome results
None listed