Juvenile Myopia, Myopia
Conditions
Brief summary
This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.
Interventions
Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
DEVICESpectacle lenses
Single vision, impact resistant spectacle lenses
Sponsors
SightGlass Vision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days; * Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); * Willingness to participate in the trial for up to 3 years without contact lens wear; * The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
Exclusion criteria
* Known allergy to proparacaine, tetracaine, or tropicamide.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 72 months | Test vs. control axial length change from baseline |
| Spherical equivalent refraction (SER) | 72 months | Test vs. control spherical equivalent refraction (SER) change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 42 months | Change from baseline |
| SER | 60 months | Change from baseline |
Countries
Canada, United States
Outcome results
None listed