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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
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive focused on measuring Myopia, Myopia control

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

First Posted
January 23, 2019
Last Updated
April 10, 2023
Sponsor
SightGlass Vision, Inc.
Collaborators
University of Waterloo
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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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