Juvenile Myopia, Myopia, Myopia Progression
Conditions
Brief summary
The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.
Interventions
DEVICEDiffusion Optics Technology (DOT) Pattern Spectacle Lens
DOT Pattern Spectacle Lens
DEVICEControl Spectacle Lens
Control Spectacles
Sponsors
SightGlass Vision, Inc.
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Are 8-14 years of age; * Are able to read (or be read to), understand and sign the assent document; * Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document; * Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively; * Are willing and able to follow instructions.
Exclusion criteria
* Are participating in any concurrent interventional clinical or research study; * Have a history of myopia control treatment in the past year; * Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency; * Have any known active ocular disease and/or infection; * Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism; * Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops; * Have undergone strabismus surgery, refractive error surgery or intraocular surgery; * Are a child of a member of the study team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Choroidal Thickness | 30 minutes and 60 minutes | Change from Baseline, 30 minutes and 60 minutes |
| Retinal and Choroidal Thickness | 30 minutes and 60 minutes | Change from Baseline, 30 minutes and 60 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Software Method Comparison | 30 minutes and 60 minutes | Comparison of measurements using different software methods; manual, semiautomated and automated software |
Countries
Canada
Outcome results
None listed