Choroidal Response to Novel Spectacle Lens to Control Myopia Progression (CHERRY)
Primary Purpose
Myopia, Progressive
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Novel spectacle lens design
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive focused on measuring Myopia, Myopia control
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;)
Sites / Locations
- Centre for Ocular Research and Education
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Subjects wearing novel spectacle lenses will be assessed
Outcomes
Primary Outcome Measures
Choroidal thickness
Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis
Secondary Outcome Measures
Visual field
Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer
Full Information
NCT ID
NCT03818880
First Posted
January 23, 2019
Last Updated
April 10, 2023
Sponsor
SightGlass Vision, Inc.
Collaborators
University of Waterloo
1. Study Identification
Unique Protocol Identification Number
NCT03818880
Brief Title
Choroidal Response to Novel Spectacle Lens to Control Myopia Progression
Acronym
CHERRY
Official Title
A Sub-Study to Assess the Choroidal Response to Novel Spectacle Lens to Control Myopia Progression (CHERRY)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.
Collaborators
University of Waterloo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
Keywords
Myopia, Myopia control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects wearing novel spectacle lenses will be assessed
Intervention Type
Device
Intervention Name(s)
Novel spectacle lens design
Intervention Description
Spectacle lens to control progression of myopia
Primary Outcome Measure Information:
Title
Choroidal thickness
Description
Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Visual field
Description
Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD, FCOptom
Organizational Affiliation
CORE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill Woods, BSc, MCOptom
Organizational Affiliation
CORE
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Ocular Research and Education
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Choroidal Response to Novel Spectacle Lens to Control Myopia Progression
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