Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

Overview

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.

Full Title of Study: “A Sub-Study to Assess the Choroidal Response to Novel Spectacle Lens to Control Myopia Progression (CHERRY)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 21, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Treatment
    • Subjects wearing novel spectacle lenses will be assessed

Clinical Trial Outcome Measures

Primary Measures

  • Choroidal thickness
    • Time Frame: 3 years
    • Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis

Secondary Measures

  • Visual field
    • Time Frame: 3 years
    • Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer

Participating in This Clinical Trial

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;)

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • SightGlass Vision, Inc.
  • Collaborator
    • University of Waterloo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lyndon Jones, PhD, FCOptom, Principal Investigator, Centre for Ocular Research & Education, Canada
    • Jill Woods, BSc, MCOptom, Study Director, Centre for Ocular Research & Education, Canada

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