Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

Myopia, Progressive Clinical Trial

— CHERRY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03818880
• Other study ID #: P/654/18/SG
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: May 1, 2024

Study information

• Verified date: December 2023
• Source: SightGlass Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 1, 2024
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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;)

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Device:
• Novel spectacle lens design
Spectacle lens to control progression of myopia

Locations

Country	Name	City	State
Canada	Centre for Ocular Research and Education	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
SightGlass Vision, Inc.	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal thickness	Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis	3 years
Secondary	Visual field	Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer	3 years