Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness

Study Overview
=================
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.

Official Title
-----------------
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes

Conditions
-----------------
Myopia, Myopia Progression, Juvenile Myopia

Intervention / Treatment
-----------------
* Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens
* Device: Control Spectacle Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1 - Diffusion Optics Technology (DOT) Pattern<br> | Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens<br>* DOT Pattern Spectacle Lens<br>|
| Active Comparator: Treatment 2 - Control Spectacles<br> | Device: Control Spectacle Lens<br>* Control Spectacles<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal Thickness | Change from Baseline, 30 minutes and 60 minutes | 30 minutes and 60 minutes | 
| Retinal and Choroidal Thickness | Change from Baseline, 30 minutes and 60 minutes | 30 minutes and 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Software Method Comparison | Comparison of measurements using different software methods; manual, semiautomated and automated software | 30 minutes and 60 minutes |