Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

Study Overview
=================
Brief Summary
-----------------
Diurnal variations in the thickness of the choroid have been reported in the literature, and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression.

Detailed Description
-----------------
Diurnal variations in the thickness of the choroid have been reported in the literature , and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression. SightGlass Vision, Inc is conducting a multi-site, randomized, controlled, interventional study to confirm the efficacy and safety of spectacle lenses designed to inhibit the progression of myopia by reducing image contrast in peripheral vision. CORE is participating as a clinical site in this three year study which aims to compare changes in ocular length and cycloplegic auto-refraction in children randomised to wear one of either two test or one control spectacle lens designs; the CPRO-1802-001 (Cypress_SG) study. The sponsor is interested in conducting choroidal thickness measurements only at CORE's site by inviting those participants who have already been found eligible for the CPRO-1802-001 study to participate in this parallel study.

Official Title
-----------------
A Sub-Study to Assess the Choroidal Response to Novel Spectacle Lens to Control Myopia Progression (CHERRY)

Conditions
-----------------
Myopia, Progressive

Intervention / Treatment
-----------------
* Device: Novel spectacle lens design


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participating in the CPRO-1802-001 (Cypress_SG) study at CORE Read and signed an Assent and their parent/guardian has signed an information consent letter Exclusion Criteria: Transient health condition which may affect the eye(s) (e.g. a common cold, active allergies, fatigue, etc;)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects wearing novel spectacle lenses will be assessed | Device: Novel spectacle lens design<br>* Spectacle lens to control progression of myopia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal thickness | Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual field | Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Myopia control