Juvenile Myopia, Myopia
Conditions
Brief summary
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of myopia in children of Chinese origin.
Interventions
Use of lenses may reduce the rate of progression of juvenile myopia
DEVICESpectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia
Sponsors
SightGlass Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children 6-13 years of age 2. SER error between -0.75D and -5.00D 3. Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear
Exclusion criteria
1. Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K) 2. Astigmatism worse than -1.50 DC (by manifest refraction) in either eye 3. Anisometropia (SER manifest refraction) greater than 1.00 D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 12 months | Change in axial length from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 24 months | Change in axial length from baseline |
Countries
China
Outcome results
None listed