Juvenile Myopia, Myopia
Conditions
Brief summary
This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.
Interventions
Use of spectacle 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 to participant's former treatment group.
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
1. Previously a successfully completed participant in the CATHAY study (NCT05562622) 2. 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) 3. Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention 4. 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
1\. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length Group I | 12 months | Change in axial length from baseline to 36 months |
| Axial length Group II | 12 months | Change in axial length from baseline to 12 months |
Countries
China
Contacts
Primary ContactJennifer S Hill, BS
Backup ContactVanessa Tasso, MA, MBA
Outcome results
None listed