Juvenile Myopia, Myopia, Myopia Progression
Conditions
Brief summary
To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses. To quantify axial length progression following cessation of use of specific spectacle lenses.
Interventions
DEVICESpectacle Lenses
Standard Spectacle Lenses
Sponsors
SightGlass Vision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Previously a successfully completed participant in the CYPRESS Extension study; * 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 12 months 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 |
|---|---|---|
| Cycloplegic Spherical Equivalent Refraction (cSER) | 12 months | Change in cSER |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic Spherical Equivalent Refraction (cSER) | 6 months | Change in cSER |
| Axial Length (AL) | 12 months | Change in AL |
Countries
United States
Outcome results
None listed